Sternal closure cerclage, plate implant and instrumentation

ABSTRACT

A system including a bone punch tool and a needle guide. The bone punch tool can include a support arm having a support arm proximal portion and a support arm distal portion, a pivot arm having a pivot arm proximal portion and a pivot arm distal portion, and an arcuate punch configured to punch through bone. The pivot arm distal portion can be pivotably coupled to the support arm distal portion, such that the pivot arm proximal portion is configured to be moved away from the support arm proximal portion to extend the arcuate punch into a punch position to punch an arcuate hole through bone. The needle guide can be configured to guide a needle through the arcuate hole.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation-in-Part of U.S. application Ser. No.15/174,041, filed Jun. 6, 2016, which application is a continuation ofU.S. application Ser. No. 14/500,010, filed Sep. 29, 2014, now issued onJun. 7, 2016 as U.S. Pat. No. 9,358,054, which application is acontinuation of International Application No. PCT/US2014/028903, filedMar. 14, 2014, which application claims the benefit of priority to U.S.Provisional Application No. 61/794,648 filed on Mar. 15, 2013, U.S.Provisional Application No. 61/794,518 filed on Mar. 15, 2013 and U.S.Provisional Application No. 61/794,290 filed on Mar. 15, 2013.

This application is a Continuation-in-Part of U.S. application Ser. No.15/174,783, filed Jun. 6, 2016, which application is a continuation ofU.S. application Ser. No. 14/500,010, filed Sep. 29, 2014, now issued onJun. 7, 2016 as U.S. Pat. No. 9,358,054, which application is acontinuation of International Application No. PCT/US2014/028903, filedMar. 14, 2014, which application claims the benefit of priority to U.S.Provisional Application No. 61/794,648 filed on Mar. 15, 2013, U.S.Provisional Application No. 61/794,518 filed on Mar. 15, 2013 and U.S.Provisional Application No. 61/794,290 filed on Mar. 15, 2013.

The entire disclosure of each of the above applications is incorporatedherein by reference.

BACKGROUND

Surgeries are often performed on humans and animals to treat disease orinjury. Such surgeries can result in the surgeon having to repair aseparated, cut or fractured bone. In the case of an injury, the surgeonmay need to immobilize and fix two or more bone portions together toallow the bone to heal over time. Treating certain diseases, such asheart disease, for example, often requires the surgeon to cut apatient's sternum to gain access to and perform a procedure on thepatient's heart. Once the heart procedure is complete, the cut sternummay be repaired by immobilizing and joining the separate portions of thesternum together to allow the sternum to heal over time. It is oftendesirable to apply a compressive force urging the bone portions togetherto facilitate healing of the bone.

OVERVIEW

To better illustrate the instrument disclosed herein, a non-limitinglist of examples is provided here:

In Example 1, a bone punch apparatus can include a support arm having asupport arm proximal portion and a support arm distal portion, a pivotarm having a pivot arm proximal portion and a pivot arm distal portion,the pivot arm distal portion pivotably coupled to the support arm distalportion, and an arcuate punch that can be configured to punch throughbone, the arcuate punch coupled to the pivot arm distal portion, andoptionally configured such that the pivot arm proximal portion movesaway from the support arm proximal portion so as to extend the arcuatepunch into a punch position.

In Example 2, the bone punch apparatus of Example 1, is optionallyconfigured such that the pivot arm proximal portion is configured to bemoved toward the support arm proximal portion to retract the arcuatepunch into a retracted position.

In Example 3, the bone punch apparatus of Example 1, is optionallyconfigured such that the pivot arm pivots about a pivot point positionedat the support arm distal portion at a center of curvature of thearcuate punch.

In Example 4, the bone punch apparatus of Example 1, can optionallyinclude a protrusion extending from the support arm distal portion andconfigured to receive a bone piercing tip of the arcuate punch when inthe punch position.

In Example 5, the bone punch apparatus of Example 4, can optionallyinclude a housing coupled to the support arm distal portion, the housingand the protrusion together defining a receptacle configured to receivea bone portion.

In Example 6, the bone punch apparatus of Example 5, is optionallyconfigured such that the receptacle is a u-shaped receptacle configuredto receive a portion of a sternum.

In Example 7, the bone punch apparatus of Example 1, is optionallyconfigured such that the arcuate punch is configured to form an arcuatehole through a bone portion.

In Example 8, the bone punch apparatus of Example 1, can optionallyinclude a locking member configured to urge the pivot arm proximalportion toward the support arm proximal portion.

In Example 9, a bone punch apparatus can include a support arm having asupport arm proximal portion, a support arm distal portion, and asupport arm alignment guide, a pivot arm having a pivot arm proximalportion and a pivot arm distal portion, the pivot arm distal portionpivotably coupled to the support arm distal portion, and an arcuatepunch configured to punch through bone, the arcuate punch coupled to thepivot arm distal portion, is optionally configured such that the supportarm alignment guide is configured to indicate an orientation of thearcuate punch.

In Example 10, the bone punch apparatus of Example 9, is optionallyconfigured such that the pivot arm proximal portion is configured to bemoved away from the support arm proximal portion to extend the arcuatepunch into a punch position, and the pivot arm proximal portion isconfigured to be moved toward the support arm proximal portion toretract the arcuate punch into a retracted position.

In Example 11, the bone punch apparatus of Example 9, is optionallyconfigured such that the support arm alignment guide includes a window.

In Example 12, the bone punch apparatus of Example 11, is optionallyconfigured such that a width of the window corresponds to a width of thearcuate punch.

In Example 13, the bone punch apparatus of Example 9, is optionallyconfigured such that the support arm alignment guide is configured toalign with a completed punch hole.

In Example 14, the bone punch apparatus of Example 9, is optionallyconfigured such that the pivot arm includes a pivot arm alignment guideconfigured to indicate an orientation of the arcuate punch.

In Example 15, a system can include a bone punch tool configured to forman arcuate hole through a bone, the bone punch tool can include asupport arm having a support arm proximal portion and a support armdistal portion, a pivot arm having a pivot arm proximal portion and apivot arm distal portion, the pivot arm distal portion pivotably coupledto the support arm distal portion, and an arcuate punch configured topunch through the bone, the arcuate punch coupled to the pivot armdistal portion, is optionally configured such that the pivot armproximal portion is configured to be moved away from the support armproximal portion to extend the arcuate punch into a punch position, anda needle guide configured to guide a needle through the arcuate hole.

In Example 16, the system of Example 15, is optionally configured suchthat the arcuate punch is dimensioned to form the arcuate hole withgeometry corresponding to an arcuate geometry of the needle.

In Example 17, the system of Example 16, is optionally configured suchthat the needle guide includes a handle, an arcuate portion coupled tothe handle, the arcuate portion configured to be inserted into thearcuate hole, and a grasping portion at an end of the arcuate portion,the grasping portion configured to grasp a tip of the needle.

In Example 18, the system of Example 17, is optionally configured suchthat the grasping portion includes a slot formed in the arcuate portion.

In Example 17, the system of Example 18, is optionally configured suchthat the grasping portion includes an aperture and at least one slotintersecting the aperture, such that the end of the arcuate portion isconfigured to expand with receipt of the needle within the aperture.

In Example 20, the system of Example 17, is optionally configured suchthat the arcuate portion is configured to be removed from the arcuatehole while grasping the needle, such that the needle guide is configuredto guide the needle through the arcuate hole.

In Example 21, the apparatus or system of any one or any combination ofExamples 1-20 can optionally be configured such that multiple or allelements or options recited are available to use or select from.

These and other examples and features of the present devices, systems,and methods will be set forth in part in the following DetailedDescription. This overview is intended to provide a summary of subjectmatter of the present patent application. It is not intended to providean exclusive or exhaustive description of the invention. The detaileddescription is included to provide further information about the presentpatent application.

BRIEF DESCRIPTION OF THE DRAWINGS

In the drawings, which are not necessarily drawn to scale, like numeralsmay describe similar components in different views. Like numerals havingdifferent letter suffixes may represent different instances of similarcomponents. The drawings illustrate generally, by way of example, butnot by way of limitation, various examples discussed in the presentdocument.

FIG. 1 is a partial perspective view of an anterior side of a sternumand ribs of a human body having a closure device attached theretoaccording to the principles of the present disclosure, in accordancewith at least one example of the present disclosure.

FIG. 2 is a perspective view of the closure device.

FIG. 3 is an exploded perspective view of the closure device.

FIG. 4 is a perspective view depicting a tensioning device of theclosure device adjustably engaging a band of the closure device.

FIG. 5 is a cross-sectional view of the closure device taken along line5-5 of FIG. 4.

FIG. 6 is a perspective view of the closure device after an end of theband has been trimmed according to the principles of the presentdisclosure.

FIG. 7 is a perspective view of the closure device after the end of theband has been bent according to the principles of the presentdisclosure.

FIG. 8 is a perspective view of the closure device and a fixturealigning a plurality of fasteners relative to the closure device.

FIG. 9 is a perspective view of the closure device and fixture of FIG. 8depicting a screwdriver driving one of the fasteners.

FIG. 10 is a perspective view of the closure device with all of thefasteners driven through a bracket of the closure device.

FIG. 11 is a perspective view of another closure device having atensioning device according to the principles of the present disclosure.

FIG. 12 is a perspective view of yet another closure device having atensioning device according to the principles of the present disclosure.

FIG. 13 is a plan view of the closure device of FIG. 12.

FIG. 14 is a perspective view of yet another closure device having atensioning device according to the principles of the present disclosure.

FIG. 12.

FIG. 15 is a cross-sectional view of the closure device of FIG. 16 is aplan view of the closure device of FIG. 14 with a locking cam of thetensioning device in an unlocked position.

FIG. 17 is a plan view of the closure device of FIG. 14 with a lockingcam of the tensioning device in a locked position.

FIG. 18 is a perspective view of yet another closure device having atensioning device according to the principles of the present disclosure.

FIG. 19 is a plan view of the closure device of FIG. 18.

FIG. 20 is a perspective view of yet another closure device according tothe principles of the present disclosure.

FIG. 21 is a perspective view of the closure device of FIG. 20 and atensioning device according to the principles of the present disclosure.

FIG. 22 is another perspective view of the closure device and tensioningdevice of FIG. 20.

FIG. 23 is yet another perspective view of the closure device andtensioning device of FIG. 20.

FIG. 24 is a perspective view of the closure device of FIG. 20 with thetensioning device removed.

FIG. 25 is another perspective view of the closure device of FIG. 20.

FIG. 26 is a perspective view of yet another closure device having atensioning device according to the principles of the present disclosure.

FIG. 27 is a cross-sectional view of the closure device and tensioningdevice of FIG. 26.

FIG. 28 is a perspective view of yet another closure device having atensioning device according to the principles of the present disclosure.

FIG. 29 is a perspective view of the closure device of FIG. 28 with thetensioning device removed.

FIG. 30 is a perspective view of yet another closure device according tothe principles of the present disclosure.

FIG. 31 is a perspective view of a bracket of the closure device of FIG.30.

FIG. 32 is a partial perspective view of the closure device of FIG. 30and a tensioning device according to the principles of the presentdisclosure.

FIG. 33 is a perspective view of the tensioning device of FIG. 32.

FIG. 34 is a partial cross-sectional view of the tensioning device andthe closure device of FIG. 32 attached to a sternum.

FIG. 35 is a cross-sectional view of the tensioning device and theclosure device of FIG. 32 attached to the sternum.

FIG. 36 is a perspective view of the closure device attached to FIG. 37is a perspective view of a clamping device and band according to theprinciples of the present disclosure.

FIG. 38 is a plan view of the clamping device and band of FIG. 37.

FIG. 39 is a cross-sectional view of the clamping device and band ofFIG. 37.

FIG. 40 is a perspective view of yet another closure device having atensioning device according to the principles of the present disclosure.

FIG. 41 is a partial perspective view of the closure device andtensioning device of FIG. 40.

FIG. 42 is a cross-sectional view of the closure device and tensioningdevice of FIG. 40.

FIG. 43 is a partial perspective view of the closure device andtensioning device of FIG. 40.

FIG. 44 is a cross-sectional view of the tensioning device and closuredevice of FIG. 40 attached to a sternum.

FIG. 45 is a perspective view of the closure device of FIG. 40.

FIG. 46 is a perspective view of yet another closure device having atensioning device according to the principles of the present disclosure.

FIG. 47 is another perspective view of the closure device and tensioningdevice of FIG. 46.

FIG. 48 is a partially exploded perspective view of the closure deviceand tensioning device of FIG. 46.

FIG. 49 is a perspective view of the closure device of FIG. 46.

FIG. 50 is a perspective view of multiple closure devices attached to asternum.

FIG. 51 is another perspective view of the closure device and tensioningdevice of FIG. 46.

FIG. 52 is a perspective view of yet another closure device having atensioning device according to the principles of the present disclosure.

FIG. 53 is a perspective view of yet another closure device having atensioning device according to the principles of the present disclosure.

FIG. 54 is a partial perspective view of the closure device of FIG. 53.

FIG. 55 is a partial cross-sectional view of the closure device andtensioning device of FIG. 53.

FIG. 56 is a perspective view of an exemplary configuration of theclosure device and tensioning device of FIG. 53.

FIG. 57 is a perspective view of multiple closure devices attached to asternum.

FIG. 58 is a partial plan view of a band and needle according to theprinciples of the present disclosure.

FIG. 59 is a partial plan view of the band of FIG. 58.

FIG. 60 is a partially cross-sectioned view of a needle passer passingthe band and needle of FIG. 58 through a sternum.

FIG. 61 is a perspective view of yet another closure device according tothe principles of the present disclosure.

FIG. 62 is a plan view of yet another closure device attached to asternum according to the principles of the present disclosure.

FIG. 63 is a cross-sectional view of yet another closure device attachedto a sternum according to the principles of the present disclosure.

FIG. 64 is a plan view of yet another closure device attached to asternum according to the principles of the present disclosure.

FIG. 65 is a perspective view of yet another closure device having atensioning device according to the principles of the present disclosure.

FIG. 66 is another perspective view of the closure device and tensioningdevice of FIG. 65.

FIG. 67 is a perspective view of the closure device and tensioningdevice of FIG. 65 in a tensioned condition.

FIG. 68 is a cross-sectional view depicting a step of a method ofclosing a sternum using another closure device according to theprinciples of the present disclosure.

FIG. 69 is a plan view depicting another step of the method of closingthe sternum using the closure device of FIG. 68.

FIG. 70 is a plan view depicting another step of the method of closingthe sternum using the closure device of FIG. 68.

FIG. 71 is a partially exploded perspective view of yet another closuredevice according to the principles of the present disclosure.

FIG. 72 is a perspective view of the closure device of FIG. 71 attachedto a sternum.

FIG. 73 is a partially exploded perspective view of yet another closuredevice according to the principles of the present disclosure.

FIG. 74 is a cross-sectional view of yet another closure deviceaccording to the principles of the present disclosure.

FIG. 75 is another cross-sectional view of the closure device of FIG.74.

FIG. 76 is a perspective view of the closure device of FIG. 74.

FIG. 77 is a partially cross-sectioned view of yet another closuredevice according to the principles of the present disclosure.

FIG. 78 is a partial plan view of a band according to the principles ofthe present disclosure.

FIG. 79 is a partial perspective view of the band of FIG. 78 with aneedle attached thereto.

FIG. 80 is a plan view of a sternum having a pair of brackets of yetanother closure device according to the principles of the presentdisclosure.

FIG. 81 is a plan view of inserts connecting the brackets according tothe principles of the present disclosure.

FIG. 82 is a cross-sectional view depicting a step of a method ofclosing a sternum using yet another closure device according to theprinciples of the present disclosure.

FIG. 83 is a cross-sectional view depicting another step of the methodof closing the sternum.

FIG. 84 is a cross-sectional view depicting yet another step of themethod of closing the sternum.

FIG. 85 is a perspective view of an anterior side of a sternum and ribsof a human body having other configurations of a closure device attachedthereto according to the principles of the present disclosure.

FIG. 86 is a cross-sectional view of the closure device taken along line86-86 of FIG. 85.

FIG. 87 is a cross-sectional view of the closure device taken along line87-87 of FIG. 85.

FIG. 88 is a perspective view of the closure device of FIG. 85.

FIG. 89 is a cross-sectional view of a crimp element of the closuredevice of FIG. 85, depicting the crimp element in a first position.

FIG. 90 is a cross-sectional view of the crimp element of FIG. 89,depicting the crimp element in a second position.

FIG. 91 is a cross-sectional view of another configuration of a crimpelement of the closure device of FIG. 85.

FIG. 92 is a plan view of a band of a closure device according to theprinciples of the present disclosure.

FIG. 93 is a plan view of another configuration of a band of a closuredevice according to the principles of the present disclosure.

FIG. 94 is a perspective view of a needle operatively connected to aband of a closure device according to the principles of the presentdisclosure.

FIG. 95 is a perspective view of another configuration of a needleoperatively connected to a band of a closure device according to theprinciples of the present disclosure.

FIG. 96 is a perspective view of another configuration of a needle of aclosure device according to the principles of the present disclosure.

FIG. 97 is a top view of the needle of FIG. 96.

FIG. 98 is a cross-sectional view of the needle of FIG. 96, taken alongthe line 98-98 of FIG. 97.

FIG. 99 is an end view of the needle of FIG. 96.

FIG. 100 is a bottom view of the needle of FIG. 96.

FIG. 101 is a perspective view of another configuration of a needle of aclosure device according to the principles of the present disclosure.

FIG. 102 is a top view of the needle of FIG. 101.

FIG. 103 is a cross-sectional view of the needle of FIG. 101, takenalong the line 103-103 of FIG. 102.

FIG. 104 is a perspective view of another configuration of a needle of aclosure device according to the principles of the present disclosure.

FIG. 105 is a top view of the needle of FIG. 104.

FIG. 106 is a cross-sectional view of the needle of FIG. 104, takenalong the line 106-106 of FIG. 105.

FIG. 107 is an end view of the needle of FIG. 104.

FIG. 108 is a perspective view of a bracket of a closure deviceaccording to the principles of the present disclosure.

FIG. 109 is a perspective view of another configuration of a bracket ofa closure device according to the principles of the present disclosure.

FIG. 110 is a cross-sectional view of a sternum and ribs of a human bodydepicting the bracket of FIG. 108 and a band attached thereto accordingto the principles of the present disclosure.

FIG. 111 is a perspective view of another configuration of a bracket ofa closure device according to the principles of the present disclosure.

FIG. 112 is a perspective view of another configuration of a bracket ofa closure device according to the principles of the present disclosure.

FIG. 113 is a perspective view of an anterior side of a sternum and ribsof a human body having another configuration of a closure deviceattached thereto according to the principles of the present disclosure.

FIG. 114 is a cross-sectional view of the closure device taken along theline 114-114 of FIG. 113.

FIG. 115A is a perspective view of another configuration of a closuredevice according to the principles of the present disclosure.

FIG. 115B is a top view of one configuration of a link member of theclosure device of FIG. 115A.

FIG. 116 is a perspective view of an anterior side of a sternum and ribsof a human body depicting the closure device of FIG. 115A attachedthereto according to the principles of the present disclosure.

FIG. 117 is a perspective view of another configuration of a closuredevice according to the principles of the present disclosure.

FIG. 118 is a partial cross-sectional view of the closure device of FIG.117.

FIG. 119 is a perspective view of an anterior side of a sternum and ribsof a human body having another configuration of a closure deviceattached thereto according to the principles of the present disclosure.

FIG. 120 is a perspective view of a tensioning device and a link ofanother configuration of a closure device according to the principles ofthe present disclosure.

FIG. 121 is a cross-sectional view of the tensioning device and linktaken through the line 120-120 of FIG. 120.

FIG. 122 is a top view of an anterior side of a sternum and ribs of ahuman body having another configuration of a closure device attachedthereto according to the principles of the present disclosure.

FIG. 123 is a top view of a link member of the closure device of FIG.122.

FIG. 124 is a perspective view of an anterior side of a sternum and ribsof a human body having another configuration of a closure deviceattached thereto according to the principles of the present disclosure.

FIG. 125 is a partial cross-sectional view of the closure device takenthrough the line 125-125 of FIG. 124.

FIG. 126 is a partial cross-sectional view of another configuration of aclosure device according to the principles of the present disclosure.

FIG. 127 is a top view of a receiver of the closure device of FIG. 126.

FIG. 128 is a top view of another configuration of a receiver of theclosure device of FIG. 126.

FIG. 129 is a perspective view of another configuration of a closuredevice according to the principles of the present disclosure.

FIG. 130 is a perspective view of an anterior side of a sternum and ribsof a human body having another configuration of a closure deviceattached thereto according to the principles of the present disclosure.

FIG. 130A is a top view of an anterior side of a sternum and ribs of ahuman body having another configuration of a closure device attachedthereto according to the principles of the present disclosure.

FIG. 130B is a cross-sectional view of the closure device taken throughthe line 130 b-130 b of FIG. 130 a.

FIG. 131 is a perspective view of an anterior side of a sternum and ribsof a human body having another configuration of a closure deviceattached thereto according to the principles of the present disclosure.

FIG. 132 is a perspective view of a portion of another configuration ofa closure device according to the principles of the present disclosure.

FIG. 133 is a top view of an anterior side of a sternum and ribs of ahuman body having another configuration of a closure device attachedthereto according to the principles of the present disclosure.

FIG. 134 is a top view of an anterior side of a sternum and ribs of ahuman body having another configuration of a closure device attachedthereto according to the principles of the present disclosure.

FIG. 135 is a cross-sectional view of the closure device taken throughthe line 135-135 of FIG. 134.

FIG. 136 is a cross-sectional view of a sternum and ribs of a human bodyhaving another configuration of a closure device attached theretoaccording to the principles of the present disclosure.

FIG. 137 is a cross-sectional view of a sternum and ribs of a human bodyhaving another configuration of a closure device attached theretoaccording to the principles of the present disclosure.

FIG. 138 is a perspective view of another configuration of a band of aclosure device.

FIG. 139 is a cross-sectional view of the band taken through the line139-139 of FIG. 138.

FIG. 140 is a perspective view of another configuration of a band of aclosure device.

FIG. 141 is a perspective view of a link of the band of FIG. 140 inanother configuration.

FIG. 142 is a perspective view of another configuration of a band and alink of a closure device.

FIG. 143 is a bottom view of the link of FIG. 142.

FIG. 144 is a perspective view of another configuration of a band and alink of a closure device according to the principles of the presentdisclosure.

FIG. 144A is a perspective view of another configuration of a band and alink of a closure device according to the principles of the presentdisclosure.

FIG. 144B is a top view of the link of FIG. 144A.

FIG. 144C is a side view of the link of FIG. 144A.

FIG. 145 is a perspective view of another configuration of a band and alink of a closure device according to the principles of the presentdisclosure.

FIG. 146 is a perspective view of another configuration of a band and alink of a closure device according to the principles of the presentdisclosure.

FIG. 147 is a perspective view of another configuration of a band and alink of a closure device according to the principles of the presentdisclosure.

FIG. 148 is a cross-sectional view of a first configuration of the linkof FIG. 147.

FIG. 149 is a cross-sectional view of a second configuration of the linkof FIG. 147.

FIG. 150 is a perspective view of another configuration of a band and alink of a closure device according to the principles of the presentdisclosure.

FIG. 151 is a top view of the link of FIG. 150 in a disassembledconfiguration.

FIG. 152 is a cross-sectional view of the link taken through the line152-152 of FIG. 151.

FIG. 153 is a perspective view of an anterior side of a sternum and ribsof a human body having another configuration of a closure deviceattached thereto in an unsecured configuration according to theprinciples of the present disclosure.

FIG. 154 is a perspective view of the closure device of FIG. 153,depicting a tool for securing the closure device.

FIG. 155 is a perspective view of the closure device of FIG. 153,depicting the closure device in a secured configuration.

FIG. 156 is a top view of another configuration of a closure deviceaccording to the principles of the present disclosure.

FIG. 157 is a perspective view of another configuration of a closuredevice according to the principles of the present disclosure.

FIG. 158 is a cross-sectional view of the closure device of FIG. 157operatively attached to a sternum.

FIG. 159 is a cross-sectional view of a portion of the closure device ofFIG. 157.

FIG. 160 is a perspective view of another configuration of a closuredevice according to the principles of the present disclosure.

FIG. 161 is a cross-sectional view of the closure device of FIG. 160operatively attached to a sternum.

FIG. 162 is a top view of an anterior side of a sternum and ribs of ahuman body having another configuration of a closure device attachedthereto in an unsecured configuration according to the principles of thepresent disclosure.

FIG. 163 is a top view of the closure device of FIG. 162, depicting theclosure device in a secured configuration.

FIG. 164 is a top view of an anterior side of a sternum and ribs of ahuman body having another configuration of a closure device attachedthereto according to the principles of the present disclosure.

FIG. 165 is a cross-sectional view of the closure device of FIG. 164taken through the line 165-165, depicting a fastener in a firstconfiguration.

FIG. 166 is a cross-sectional view of the closure device of FIG. 164taken through the line 165-165, depicting a fastener in a secondconfiguration.

FIG. 167 is a partial cross-sectional view of the closure device of FIG.164, depicting an alternative configuration for securing a cover.

FIG. 168 is a perspective view of another configuration of a closuredevice according to the principles of the present disclosure, depictinga tool for configuring the closure device.

FIG. 169 is a perspective view of the closure device of FIG. 168,depicting a hook portion associated with the closure device.

FIG. 170 is a top view of an anterior side of a sternum and ribs of ahuman body having another configuration of a closure device attachedthereto according to the principles of the present disclosure.

FIG. 171 is a perspective view of a portion of the closure device ofFIG. 170.

FIG. 172 is a cross-sectional view of the closure device of FIG. 170taken through the line 172-172 of FIG. 171.

FIG. 173 is a top of another configuration of a closure device accordingto the principles of the present disclosure.

FIG. 174 is a cross-sectional view of the closure device of FIG. 173,depicting the closure device attached to a sternum of a human body.

FIG. 175 is a top view of another configuration of a closure deviceaccording to the principles of the present disclosure.

FIG. 176 is a cross-sectional view of the closure device of FIG. 175,depicting a fastener in an unsecured configuration.

FIG. 177 is a cross-sectional view of the closure device of FIG. 175,depicting a fastener in a secured configuration.

FIG. 178 is a perspective view of another configuration of a closuredevice according to the principles of the present disclosure; and

FIG. 179 is a cross-sectional view of the closure device of FIG. 178,depicting the closure device attached to a sternum of a human body.

FIG. 180 is a perspective view of a bone punch tool in a retractedposition, in accordance with at least one example of the presentdisclosure.

FIG. 181 is a perspective view of the bone punch tool of FIG. 180 inpunch position, in accordance with at least one example of the presentdisclosure.

FIGS. 182A and 182B are a perspective view and a top view, respectively,of the bone punch tool of FIGS. 180 and 181 engaging a manubrium in theretracted position, in accordance with at least one example of thepresent disclosure.

FIGS. 183A and 183B are a perspective view and a top view, respectively,of the bone punch tool of FIGS. 180-182B engaging the manubrium in thepunch position, in accordance with at least one example of the presentdisclosure.

FIG. 184 is a perspective view of a needle guide, in accordance with atleast one example of the present disclosure.

FIGS. 185A and 185B are perspective views of the needle guide of FIG.184 inserted through an arcuate hole in a bone, in accordance with atleast one example of the present disclosure.

FIGS. 186A and 186B are perspective views of the needle guide of FIGS.184-185B engaging a needle, in accordance with at least one example ofthe present disclosure.

FIGS. 187A and 187B are perspective views of the needle guide of FIGS.184-186B guiding the needle through the arcuate hole, in accordance withat least one example of the present disclosure.

DETAILED DESCRIPTION

Example embodiments will now be described more fully with reference tothe accompanying drawings.

Example embodiments are provided so that this disclosure will bethorough, and will fully convey the scope to those who are skilled inthe art. Numerous specific details are set forth such as examples ofspecific components, devices, and methods, to provide a thoroughunderstanding of embodiments of the present disclosure. It will beapparent to those skilled in the art that specific details need not beemployed, that example embodiments may be embodied in many differentforms and that neither should be construed to limit the scope of thedisclosure. In some example embodiments, well-known processes,well-known device structures, and well-known technologies are notdescribed in detail.

The terminology used herein is for the purpose of describing particularexample embodiments only and is not intended to be limiting. As usedherein, the singular forms “a,” “an,” and “the” may be intended toinclude the plural forms as well, unless the context clearly indicatesotherwise. The terms “comprises,” “comprising,” “including,” and“having,” are inclusive and therefore specify the presence of statedfeatures, integers, steps, operations, elements, and/or components, butdo not preclude the presence or addition of one or more other features,integers, steps, operations, elements, components, and/or groupsthereof. The method steps, processes, and operations described hereinare not to be construed as necessarily requiring their performance inthe particular order discussed or illustrated, unless specificallyidentified as an order of performance. It is also to be understood thatadditional or alternative steps may be employed.

When an element or layer is referred to as being “on,” “engaged to,”“connected to,” or “coupled to” another element or layer, it may bedirectly on, engaged, connected or coupled to the other element orlayer, or intervening elements or layers may be present. In contrast,when an element is referred to as being “directly on,” “directly engagedto,” “directly connected to,” or “directly coupled to” another elementor layer, there may be no intervening elements or layers present. Otherwords used to describe the relationship between elements should beinterpreted in a like fashion (e.g., “between” versus “directlybetween,” “adjacent” versus “directly adjacent,” etc.). As used herein,the term “and/or” includes any and all combinations of one or more ofthe associated listed items.

Although the terms first, second, third, etc. may be used herein todescribe various elements, components, regions, layers and/or sections,these 17 elements, components, regions, layers and/or sections shouldnot be limited by these terms. These terms may be only used todistinguish one element, component, region, layer or section fromanother region, layer or section. Terms such as “first,” “second,” andother numerical terms when used herein do not imply a sequence or orderunless clearly indicated by the context. Thus, a first element,component, region, layer or section discussed below could be termed asecond element, component, region, layer or section without departingfrom the teachings of the example embodiments.

Spatially relative terms, such as “inner,” “outer,” “beneath,” “below,”“lower,” “above,” “upper,” and the like, may be used herein for ease ofdescription to describe one element or feature's relationship to anotherelement(s) or feature(s) as illustrated in the figures. Spatiallyrelative terms may be intended to encompass different orientations ofthe device in use or operation in addition to the orientation depictedin the figures. For example, if the device in the figures is turnedover, elements described as “below” or “beneath” other elements orfeatures would then be oriented “above” the other elements or features.Thus, the example term “below” can encompass both an orientation ofabove and below. The device may be otherwise oriented (rotated 90degrees or at other orientations) and the spatially relative descriptorsused herein interpreted accordingly.

With reference to FIG. 1, a closure system according to the principlesof the present disclosure is generally identified with reference numeral10. The system 10 is depicted operatively associated with a sternum 12of a human body. The sternum 12, as shown, has previously undergone amedical procedure known as median sternotomy. As a result of thisprocedure, the sternum 12 has been severed, thus permitting a physicianaccess to tissues and/or organs located in the patient's thoraciccavity. However, the sternum 12 has since been reapproximated such thatthe previously severed portions 12 a, 12 b are now bound together by thesystem 10.

With continued reference to FIGS. 1-10, the system 10 may include acerclage or band 14, a bracket 16, and a tensioning device 18. As shownin FIG. 2, a needle 20 may be temporarily attached to a first end 22 ofthe band 14. The needle 20 may be attached to the first end 22 mayfasteners 18 and/or a press or snap fit, for example. A second end 24 ofthe band 14 may be fixed to the tensioning device 18. The band 14 may bea flat, elongated and flexible member formed from a metallic materialand/or a polymeric material, for example. In some embodiments, the band14 could include a braided material. The band 14 may include a pluralityof parallel slots 26 formed therein. In some embodiments, a sleeve 28(FIGS. 2 and 3) may receive a portion of the band 14. In someembodiments, the sleeve 28 may be molded over the band 14 or otherwiseintegrally formed therewith.

The bracket 16 may be a plate formed from a metallic and/or polymericmaterial and may include a body portion 30 and a plurality of legs 32extending outward from the body portion 30. The bracket 16 may berelatively flexible to enable the bracket 16 to conform to the contoursof the sternum 12 when the bracket 16 is fastened thereto (as shown inFIG. 1). The body portion 30 may include an opening 34 extendingtherethrough. The opening 34 may allow the bracket 16 to be readily cutusing band cutters, for example, or other standard operating room toolsin case the sternum 12 needs to reopened after installation of thesystem 10. The body portion 30 may also include a plurality of tabs 36that cooperate to define a channel 38 through which the band 14 isslidably received. Each of the plurality of legs 32 may include one ormore apertures 40 extending therethrough. Self-tapping threadedfasteners 42 may extend through the apertures 40 and may threadablyengage the sternum 12 to fix the bracket 16 to the sternum 12 (as shownin FIG. 1).

The tensioning device 18 may include a receiver 44 and a tensioningscrew 46. The receiver 44 may include a body portion 48 and a tab 50. Asshown in FIG. 5, the body portion 48 may include a recess 52, a firstopening 54 and a second opening 56. The first and second openings 54, 56may be generally adjacent each other and are in communication with therecess 52. The tab 50 may extend outward from the body portion 48 andmay fixedly engage the second end 24 of the band 14. The second end 24may be received within a slot 58 (FIG. 5) in the tab 50 and may be fixedtherein by pins, welding, crimping, and/or one or more fasteners, forexample, or any other suitable means.

As shown in FIG. 5, the tensioning screw 46 may include a head portion60 and a stem 62. The head portion 60 may include threads 64 and 19 oneor more slots 66 that can receive the tip of a screwdriver. The headportion 60 may be received in the recess 52 of the receiver 44 so thatthe stem 62 extends through the first opening 54 of the receiver 44. Asshown in FIG. 5, the second end 22 of the band 14 may be insertedthrough the second opening 56 and the recess 52 of the receiver 44. Thethreads 64 of the tensioning screw 46 may engage the slots 26 in theband 14 such that when the tensioning screw 46 is rotated relative tothe receiver 44, the band 14 is moved up or down (relative to the frameof reference of FIG. 5) relative to the receiver 44 based on thedirection that the tensioning screw 46 is rotated.

With continued reference to FIGS. 1-10, a method will be described forattaching the system 10 to the sternum 12 and tensioning the band 14 toreapproximate the sternum 12. With the needle 20 attached to the firstend 22 of the band 14 (as shown in FIG. 2), the first end 22 of the band14 may be looped around the posterior side of the sternum 12 so that theband 14 substantially circumscribes the sternum 12. Once the band 14 islooped around the sternum 12, the needle 20 may be removed from the band14, and the first end 22 of the band 14 may be inserted up through thereceiver 44 (as shown in FIG. 5). As shown in FIG. 1, the bracket 16 maybe positioned so that the fracture separating the two portions 12 a, 12b of the sternum 12 is visible in the opening 34 in the bracket 16(i.e., so that the two of the legs 32 of the bracket 14 are aligned withone portion 12 a, 12 b of the sternum 12 and the other two legs 32 arealigned with the other portion 12 a, 12 b of the sternum 12).

The tensioning device 18 may be used to tighten the band 14 around thesternum 12 to bind the portions 12 a, 12 b of the sternum 12 together.As described above, the tensioning screw 46 may be rotated relative tothe receiver 44 to move the band 14 up (relative to the frame ofreference of FIG. 5) to tighten the band 14 around the sternum 12 to adesired amount. Once the band 14 has been tightened to the desiredamount, the first end 22 of the band 14 may be trimmed (as shown in FIG.6) and subsequently folded over onto the tab 50 of the receiver 44 (asshown in FIG. 7).

With the band 14 sufficiently tightened around the sternum 12, thebracket 16 may be fixed to the sternum 12 with the fasteners 42. Thatis, the fasteners 42 may be inserted through the apertures 40 in thebracket 16 and 20 driven into the sternum 12 using a screwdriver (e.g.,a manual screwdriver or an electric screwdriver). As shown in FIGS. 8and 9, a fixture 68 may be employed to hold the fasteners 42 as they aredriven through the apertures 40 and into the sternum 12. The fixture 68may include a plurality of tubes 70 having apertures 72 sized to receivethe fasteners 42. The tubes 70 may have the same spacing and relativeorientation as that of the apertures 40 so that the fixture 68 can bealigned relative to the bracket 16 such that the apertures 72 arealigned with the apertures 40 (as shown in FIG. 8). With the fixture 68in this position, a screwdriver 74 (FIG. 9) can drive the fastenersthrough the apertures 72, 40 and into the sternum 12.

While the system 10 is described above as including the bracket 16, itwill be appreciated that the band 14 and tensioning device 18 could beused without the bracket 16 to reapproximate the sternum 12.

With reference to FIG. 11, another closure system 110 is provided. Thesystem 110 may include a band 114, a bracket 116, and a tensioningdevice 118. The structures and functions of the band 114, bracket 116and tensioning device 118 may be similar or identical to that of theband 14, bracket 16 and tensioning device 18 described above, apart fromany exceptions described below and/or shown in the figures. Therefore,similar features may not be described again in detail.

The band 114 may include a first end 122 and a second end 124. The band114 may extend through a slot 119 formed in the tensioning device 118.The second end 124 may include an enlarged portion or loop 125 thatprevents the second end 124 from sliding through the slot 119. In thismanner, interference between the loop 125 and the slot 119 fixes thesecond end 124 relative to the tensioning device 118 when the first end122 is pulled taught by tensioning screw 146 of the tensioning device118. Like the bracket 16, the bracket 116 may include a body 130 and aplurality of legs 132. Instead of tabs 36, the body 130 may include aplurality of ribs 133 that define a channel 138 through which the band114 is received.

With reference to FIGS. 12 and 13, another closure system 210 isprovided. The system 210 may include a band 214, a bracket 216, atensioning device 218 and a detachable fixture device 219. Thestructures and functions of 21 the band 214, bracket 216 and tensioningdevice 218 may be similar or identical to that of the band 14, bracket16 and tensioning device 18 described above, apart from any exceptionsdescribed below and/or shown in the figures. Therefore, similar featuresmay not be described again in detail.

As described above, the tensioning device 218 may include a receiver 244and a tensioning screw 246 that may be similar or identical to thereceiver 44 and tensioning screw 46 described above. The fixture device219 may include a base portion 221, a barrel portion 223 and a tongueportion 225. The barrel and tongue portions 223, 225 may extend upwardfrom the base portion 221. The barrel portion 223 may define an aperture227 that may threadably receive the tensioning screw 246 of thetensioning device 218. The tongue portion 225 may be spaced apart fromthe barrel portion 223 such that a passageway 229 is definetherebetween.

When tensioning the band 214 around the sternum 12, the fixture device219 may be placed over the receiver 244 so that the passageway 229 canreceive the free end of the band 214 extending upward from the receiver244 and so that the aperture 227 is generally aligned with a recess 252of the receiver 244.

With the fixture device 219 in this position, a surgeon may threadablyadvance the tensioning screw 246 through the aperture 227 in the fixturedevice 219 and into the recess 252 of the tensioning device 218 toengage slots 226 in the band 214 to pull the free end of the band 214through the tensioning device 218 in the manner described above. Thefixture device 219 can be removed from the tensioning device 218 oncethe tensioning screw 246 is securely engaged with the receiver 244 oronce the band 214 has been tensioned to a desired degree. The barrel andtongue portions 223, 225 of the fixture device 219 provide additionalsurface area that the surgeon can grip when inserting the tensioningscrew 246 into the receiver 244 and tensioning the band 214. The barrelportion 223 may hold the tensioning screw 246 in a position aligned withthe recess 252 in the receiver 244 so that the surgeon can easilythreadably advance the tensioning screw 246 into the receiver 244.

With reference to FIGS. 14-17, another closure system 310 is provided.The system 310 may include a band 314, a bracket 316, a locking device317, and a detachable tensioning device 318. The structures and 22functions of the band 314 and bracket 316 may be similar or identical tothat of the band 14 and bracket 16 described above, apart from anyexceptions described below and/or shown in the figures. Therefore,similar features may not be described again in detail.

The locking device 317 may include a receiver 344, a locking cam 345,and a tab 346. The receiver 344 may include a recess 348 that receives ahead 347 of the locking cam 345. The recess 348 may be in communicationwith a threaded aperture 352 that threadably engages a threaded shaft349 (FIG. 15) of the locking cam 345. The receiver 344 may include afirst slot 350 in communication with the recess 348 through which afirst end 322 of the band 314 may extend. The receiver 344 may alsoinclude a second slot 351 that receives a second end 324 of the band314. The second end 324 of the band 314 may be fixed in the second slot351 by pins, welding, crimping, and/or one or more fasteners, forexample, or any other suitable means.

A periphery of the head 347 of the locking cam 345 may include a flatportion 354 and a round portion 356. The tab 346 may be a generallyL-shaped member having a first leg 358 and a second leg 360 (FIG. 15).The first leg 358 may be disposed between the head 347 and the axial endof the recess 348 and may include an aperture 362 through which theshaft 349 of the locking cam 345 extends. The second leg 360 may extendupward from the first leg 358 adjacent the periphery of the head 347.

The locking cam 345 may be movable between an unlocked position (FIGS.14-16) and a locked position (FIG. 17). In the unlocked position, theflat portion 354 of the locking cam 345 may be facing the portion of theband 314 extending through the first slot 350 of the receiver 344 andmay allow the band 314 to freely move through the first slot 350. In thelocked position, the round portion 356 of the locking cam 345 may forcethe second leg 360 of the tab 346 against the portion of the band 314extending through the first slot 350, thereby clamping the band 314 inplace relative to the receiver 344. Once the band 314 has been tensionedby the tensioning device 318 (as described below) to a desired amount, asurgeon may use a screwdriver to engage slots in the head 347 of thelocking cam 345 to threadably move the locking cam 345 from the unlockedposition to the locked position.

In some embodiments, the locking device 317 may not include the tab 346,and in such embodiments, the round portion 356 may press directlyagainst the band 314 to clamp the band 314 in place. In someembodiments, the periphery of the head 347 may include a thread or oneor more annular ribs that engages one or more of the slots 326 of theband 314 when the locking cam 345 is in the locked position to fix theband 314 relative to the receiver 344.

The tensioning device 318 may include a base 370 and a tensioning screw372. The base 370 may include a pair of legs 374 and an upright portion376 that extends upward from the legs 374. In some embodiments, the legs374 may include apertures 375 for temporarily fastening the base 370 tothe sternum 12. The receiver 344 of the locking device 317 may nestwithin a recess 377 formed in the legs 374 (as shown in FIG. 14). Theupright portion 376 may include a receiver 378 and a reaction platform380. As shown in FIG. 15, the receiver 378 may include a recess 382, anaperture 384 in communication with the recess 382, and a slot 386 incommunication with the recess 382.

The tensioning screw 372 may include a threaded head 388 and a shaft 390extending from the head 388. The head 388 may be received in the recessand non-threadably rotatable therein. The shaft 390 may extend throughthe aperture 384 in the receiver 378. A distal end 391 of the shaft 390may contact the reaction platform 380.

To tension the band 314 around the sternum 12, the first end 322 of theband 314 may first be inserted through the slot 386 in the receiver 378so that the threads on the head 388 can engage the slots 326 in the band314. Then, with the locking cam 345 in the unlocked position, thesurgeon may use a screwdriver to turn the tensioning screw 372 relativeto the receiver 378, thereby pulling the band 314 upward (relative tothe view shown in FIG. 15) through the receiver 378. Once the band 314is sufficiently taught around the sternum 12, the surgeon may turn thelocking cam 345 to the locked position to fix the band 314 relative tothe receiver 344 of the locking device 317. Thereafter, the tensioningdevice 318 can be removed, and the first end 322 of the band 314 can betrimmed, as desired.

With reference to FIGS. 18 and 19, another closure system 410 isprovided. The system 410 may be similar to the system 10 describedabove, apart from any differences described below and/or shown in thefigures. Therefore, similar features will not be described again indetail. The system 410 may include a band 414, a bracket 416, and atensioning device 418. The structure and function of the band 414,bracket 416 and tensioning device 418 may be similar or identical tothat of the band 14, bracket 16 and tensioning device 18 describedabove, apart from the differences described above.

One end 424 of the band 414 may be received in a channel 420 formed inthe bracket 416 and fixed therein by one or more pins (not shown),fasteners (not shown), crimping and/or any other suitable means. Theother end 422 of the band 414 may be received through the tensioningdevice 418.

The tensioning device 418 may include a receiver 444 and a tensioningscrew 446. The receiver 444 may be fixedly attached to or integrallyformed with the bracket 416 and may rotatably receive the tensioningscrew 446 therein. A slot 448 may be formed in the receiver 444 throughwhich the end 424 of the band 414 may be received. A radial periphery ofthe tensioning screw 446 may engage slots 426 in the band 414 so thatwhen the tensioning screw 446 is rotated (e.g., with a screwdriver), theband 414 is advanced through the slot 448. In this manner, the band 414can be tensioned around the patient's bone and/or other tissue in themanner described above. Once the band 414 has been tensioned to adesired amount, the end 422 of the band 414 may be trimmed and/or foldedover.

With reference to FIGS. 20-25, another closure system 510 is provided.The system 510 may include a band 514, a bracket 516, a clamp 517 and atensioning device 518 (FIGS. 21-23). The band 514 and bracket 516 can besimilar to the bands and brackets described above. Therefore, similarfeatures will not be described again in detail.

One end 524 of the band 514 may be received in a channel 520 formed inthe bracket 516 and fixed therein by one or more pins (not shown),fasteners (not shown), crimping and/or any other suitable means. Theother end 522 of the band 514 may be received through the clamp 517 andthe tensioning device 518.

The clamp 517 may be a generally flat member including a pair ofapertures 527 formed therein. The apertures 527 may be aligned with apair of apertures 540 formed in the bracket 516 so that a pair offasteners 542 may be driven through the apertures 527, 540, as shown inFIGS. 23-25. As shown in FIGS. 20-25, the band 514 may be disposedbetween the clamp 517 and the bracket 516 so that when the fasteners 542are tightened within the apertures 527, 540, the band 514 may be fixedlyclamped between the clamp 517 and the bracket 516.

Prior to fixedly clamping the band 514 between the clamp 517 and thebracket 516, the band 514 may be tensioned around the patient's boneand/or tissue using the tensioning device 518. The tensioning device 518may include a base 544 and a tensioning lever 546. The base 544 mayinclude a pair of generally L-shaped legs 548 that rotatably support thetensioning lever 546 therebetween. The tensioning lever 546 may includea main body 550 having a pair of pegs 552 extending therefrom. The pegs552 may rotatably engage the legs 548 of the base 544. The tensioninglever 546 may be rotatable relative to the base 544 about an axisdefined by the pegs 552 between a first position (FIG. 21) and a secondposition (FIGS. 22 and 23). A first arm 554 (FIG. 21) may extend fromthe main body 550 in a first direction and may include first and secondtabs 556, 557 that engage the band 514. A second arm 558 may extend fromthe main body 550 in a second direction opposite the first direction andmay include an aperture 560 formed therein.

To tension the band 514 around the patient's bone and/or tissue usingthe tensioning device 518, the end 522 of the band 514 may be loopedaround the first tab 556 and under the second tab 557 with thetensioning lever 546 in the first position, as shown in FIG. 21. Theband 514 may be manually pulled taught to remove the slack in the band514 around the bone and/or tissue and so that the band 514 is fixedrelative to the first and second tabs 556, 557. Then, the tensioninglever 546 may be rotated relative to the base 544 to the secondposition, as shown in FIGS. 22 and 23. Moving the tensioning lever 546to the second position may further tighten the band 514 around the boneand/or tissue. The tensioning lever 546 can be rotated to the secondposition by gripping the first and/or second arms 554, 558 manually orwith a tool such as pliers or vice 26 grips, for example. The tensioninglever 546 could also be rotated to the second position by inserting ascrewdriver or other tool into the aperture 560 in the second arm 558and forcing the tensioning lever 546 to the second position using thescrewdriver. With the tensioning lever 546 in the second position, thefasteners 542 can be tightened to clamp the band 514 between the clamp517 and the bracket 516, thereby fixing the band 514 in the tensionedcondition, as shown in FIGS. 24 and 25.

After tensioning and clamping the band 514, the tensioning lever 546 canbe moved back to the first position so that the band 514 can be removedfrom the tensioning lever 546 and the tensioning device 518 can beremoved from the bracket 516. The end 522 of the band 514 can then betrimmed to a desired length. As shown in FIG. 25, additional fasteners543 can be used to fasten the bracket 516 to the bone and/or tissue.

With reference to FIGS. 26 and 27, another closure system 610 isprovided. The system 610 may include a band 614, a bracket 616, a clamp617 and a tensioning device 618. The structure and function of the band614, bracket 616 and clamp 617 can be similar or identical to that ofthe band 514, bracket 516 and clamp 517 described above. Therefore,similar features will not be described again in detail. While the band514 described above may not necessarily include slots or apertures, theband 614 may include slots 626 or apertures, as shown in FIGS. 26 and27.

The tensioning device 618 may include a base 644 and a tensioning screw646. The base 644 may include a recess 648 and a channel 650 incommunication with the recess 648. The tensioning screw 646 may besimilar or identical to the tensioning screw 46, for example, and may berotatably received in the recess 648. The base 644 may be placed over oron the bracket 616 so that an end 622 of the band 614 may be receivedthrough the channel 650 and into the recess 648 as shown in FIG. 27.Threads 652 of the tensioning screw 646 may engage the slots 626 in theband so that the band 614 is advanced through the channel 650 as thetensioning screw is rotated relative to the base 644. The tensioningscrew 646 may be rotated until the band 614 has been tensioned, asdesired, around the patient's bone and/or tissue. Once tensioned,fasteners 642 may tighten the clamp 617 against the bracket 616 to fix27 the band in the tensioned condition. Thereafter, the end 622 of theband 614 can be trimmed so that the tensioning device 618 can be removedfrom the bracket 616.

With reference to FIGS. 28 and 29, another closure system 710 isprovided. The system 710 may include a band 714, a bracket 716 and atensioning device 718. The structure and function of the band 714 andbracket 716 can be similar or identical to that of the band 514 andbracket 516 described above. Therefore, similar features will not bedescribed again in detail.

The bracket 716 may include a channel 720 in which an end 724 of theband 714 is fixedly received and a sleeve 721 in which another end 722of the band 714 is received. The sleeve 721 may include an aperture 723extending therethrough. As shown in FIG. 29, a fastener 743 may bedriven through the aperture 723 and through the band 714 to fix the end722 relative to the bracket 716 once the band 714 has been tensionedusing the tensioning device 718.

The tensioning device 718 may include a base 744 and a tensioning pin746. The base 744 may be a generally H-shaped member and may fit over oron the bracket 716, as shown in FIG. 28. The base 744 may rotatablysupport the tensioning pin 746. The tensioning pin 746 may include ahead 748 and a shaft 750. The head 748 may include one or more apertures752 adapted to receive a shaft of a screwdriver or a wrench (not shown),for example, or any other elongated object that can be inserted throughone of the apertures 752 and used as a lever for rotating the tensioningpin 746. The shaft 750 of the tensioning pin 746 may include a slot 754that extends radially therethrough.

As shown in FIG. 28, the end 722 of the band 714 may be received thoughthe slot 754. Once the band 714 is received through the slot 754, thetensioning pin 746 may be rotated, thereby wrapping the band 714 aroundthe shaft 750 and applying a tensioning force on the band 714. Thetensioning pin 746 can be rotated until the band 714 is sufficientlytensioned around the patient's bone and/or tissue. After the band 714 issufficiently tensioned, the fastener 743 may be driven through theaperture 723 and through the band 714 to fix the band 714 relative tothe bracket 716 in the tensioned condition, as shown in FIG. 29.Thereafter, the end 722 of the band 714 can be trimmed and thetensioning device 718 can be removed from the bracket 716, as shown inFIG. 29.

With reference to FIGS. 30-36, another closure system 810 is provided.The system 810 may include a band 814, a bracket 816 and a tensioningdevice 818 (FIGS. 32-35). The bracket 816 may include a body 819 and aplurality of feet 820 extending therefrom. A mounting aperture 821 mayextend through each foot 820 and may receive a fastener 813 (FIG. 36) tosecure the bracket 816 to the sternum 12. The body 819 may include acentral opening 822 and a pair of passages 823 in communication with theopening 822. A pair of cleats 824 may be disposed within the opening 822and may be pivotable relative to the body 819 between an unlockedposition (FIGS. 30, 31, 34 and 35) allowing ends 825 of the band 814 tofreely slide through the passages 823 and opening 822 and a lockedposition (FIG. 36) fixing the ends 825 of the band 814 relative to thepassages 823 and opening 822. The cleats 824 may be configured so thatthe ends 815 of the band 814 can be pulled up through the centralopening 822, but the cleats 824 will move into the locked position assoon as the ends 815 begin to move back through the central opening inthe opposite direction. That is, the cleats 824 will allow the band 814to be tensioned, but will move into the locked position to prevent theband 814 from loosening, unless they are manually held in the unlockedposition.

Referring now to FIGS. 32-35, the tensioning device 818 may include abase 826, an outer tube 827, an inner tube 828, a first gripping member829 and a second gripping member 830. The base 826 may define a recess831 within which the outer tube 827 and inner tube 828 may be received.The base 826 may include feet 832 that matingly engage notches 833 inthe bracket 816, as shown in FIG. 32.

The outer tube 827 may include a spiral groove 834 formed in its innerdiametrical surface. The inner tube 828 may be received within the outertube 827 and may include a pair of axially extending grooves 835 formedthrough the inner and outer diametrical surfaces of the inner tube 828.The first gripping member 829 may be disposed within the inner tube 828and may include a pair of pegs 836 and a tapered central aperture 837.Each of the pegs 836 may extend through a corresponding one of theaxially extending grooves 835 in the inner tube 828 and slidably engagethe spiral groove 834 in the outer tube 827. In this manner, relativerotation between the outer and inner tubes 827, 828 causes axial 29movement of the first gripping member 829 within the inner tube 828.That is, the pegs 836 move axially along the axially extending grooves835 as the outer tube 827 rotates relative to the inner tube 828. One ormore handles 838 (FIG. 33) may extend outward from the outer tube 827which may be gripped by a surgeon to facilitate rotation of the outertube 827 relative to the inner tube 828.

The second gripping member 830 may be disposed within the taperedcentral aperture 837 of the first gripping member 829. The secondgripping member 830 may be axially movable relative to the firstgripping member 829 between an unlocked position (FIG. 34) and a lockedposition (FIG. 35) in which ends 815 of the band 814 are gripped betweenthe first and second gripping members. When the second gripping member830 is in the locked position, upward axial movement of the firstgripping member 829 (i.e., during rotation of the outer tube 827relative to the inner tube 828) causes the first and second grippingmembers 829, 830 to pull the ends 815 of the band 814 upward relative tothe bracket 816, thereby tensioning the band 814 around the sternum 12.

With reference to FIGS. 37-39, a clamping device 900 is provided thatcan fixedly retain a band 914 and can be fixed to the patient's boneand/or any of the brackets described above, for example. The band 914can be similar or identical to any of the bands described above. It willbe appreciated that a pair of clamping devices 900 can be used tofixedly retain first and second respective ends of the band 914.

The clamping device 900 may include a central portion 904 and laterallyouter portions 906. Each of the outer portions 906 may include amounting aperture 908 extending therethrough. Fasteners (not shown) mayextend through the mounting apertures 908 to fix the clamping device 900directly to a patient's bone or to a bracket (e.g., any of the bracketsdescribed herein).

The central portion 904 may include a channel 910 that extends throughfirst and second sides 916, 918 of the central portion 904. The channel910 may receive the band 914. A threaded aperture 912 (FIG. 39) mayextend partially through the central portion 904 and may communicatewith the channel 910. A boss 919 (FIG. 39) may be formed in the channel910. The boss 919 may be substantially concentric with the threadedaperture 912 or centered on a longitudinal axis of the threaded aperture912.

A screw 920 may threadably engage the threaded aperture 912. The screw920 may include a first end 922 having one or more slots 924 (or ahexagonal socket) for engaging a screwdriver and a second end 926 havinga depression 928 formed therein. The depression 928 may be sized andpositioned so that the boss 919 may be at least partially receivedtherein.

To fix the band 914 within the channel 910, the screw 920 may bethreadably advanced through the threaded aperture 912 and into thechannel 910 with the band 914 disposed between the boss 919 and thesecond end 926 of the screw 920. The screw 920 may be tightened down onthe band 914 to compress the band 914 between the screw 920 and the boss919. Compressing the band 914 between the screw 920 and the boss 919 maydeform the band 914 around the boss 919 and into the depression 928,thereby fixedly retaining the band 914 in the channel 910.

With reference to FIGS. 40-45, another closure system 1010 is provided.The system 1010 may include a band 1014 (FIGS. 43-45), a bracket 1016and a tensioning device 1018. The band 1014 can be similar or identicalto any of the bands described herein. The bracket 1016 may includeopenings 1017 (FIGS. 44 and 45) that receive respective ends 1022, 1024of the band 1014. The bracket 1016 may also include a plurality ofmounting apertures 1019 that receive fasteners 1021 for securing thebracket 1016 to the patient's bone 12 and/or tissue.

The tensioning device 1018 may include a base 1044 and a tensioning tube1046. The base 1044 may be mounted over and/or on the bracket 1016 andmay include a main body 1048 and a plurality of fastener guides 1050.The main body 1048 may include a central aperture 1052 extendingtherethrough. The main body 1048 may include one or more resilientlyflexible ratchet tabs 1054 disposed at a periphery of the centralaperture 1052 and extending from the main body 1048 in an axialdirection (i.e., in a direction substantially parallel to a longitudinalaxis of the central aperture 1052.

The fastener guides 1050 may be cylindrical or partially cylindricalmembers having apertures 1058 extending therethrough that are alignedwith mounting apertures 1019 of the bracket 1016. The fasteners 1021 maybe received in the fastener guides 1050 and temporarily held inalignment 31 with the mounting apertures 1019 before and/or while thesurgeon drives the fasteners 1021 through the mounting apertures 1019and into the bone 12. A pair of mounting tabs 1056 may extend downwardfrom corresponding pairs of fastener guides 1050 so that the bracket1016 may be received therebetween to restrict or prevent the base 1044from sliding relative to the bracket 1016. In some embodiments, the tabs1056 may clip the base 1044 to the bracket 1016.

The tensioning tube 1046 may include a main body 1060 and a pair ofclamping members 1062. The main body 1060 may be a generally cylindricalmember having an aperture 1064 extending therethrough and along alongitudinal axis of the main body 1060. A first end 1066 of the mainbody 1060 may include a plurality of teeth 1068 and may be rotatablyreceived in the aperture 1052 of the main body 1048 of the base 1044.The teeth 1068 and the ratchet tabs 1054 of the base 1044 may cooperateto form a ratcheting mechanism that allows the tensioning tube 1046 torotate relative to the base 1044 in a clockwise direction (relative tothe view shown in FIG. 42), but restricts or prevents rotation of thetensioning tube 1046 relative to the base 1044 in a counterclockwisedirection (relative to the view shown in FIG. 42).

The clamping members 1062 may be threadably engaged with apertures 1070(FIG. 44) that extend through a second end 1072 of the main body 1060.The apertures 1070 are axially aligned with each other and may extendsubstantially perpendicular to the aperture 1064 in the main body 1060.As shown in FIG. 44, the clamping members 1062 may be threaded into theapertures 1070 toward each other and may clamp ends 1022, 1024 of theband 1014 therebetween.

To secure the band 1014 and bracket 1016 to the patient's bone 12, theends 1022, 1024 of the band 1014 may be passed through the openings 1017in the bracket 1016 after the band 1014 is looped around the boneportions 12 a, 12 b. In some embodiments, one or more guide pins 1080extending from the base 1044 may be inserted in the seam between thebone portions 12 a, 12 b to facilitate alignment of the bracket 1016relative to the bone portions 12 a, 12 b.

After passing the ends 1022, 1024 of the band 1014 through the openings1017, the ends 1022, 1024 may be inserted up through the aperture 1052of the base 1044 and the aperture 1064 of the tensioning tube 1046. The32 clamping members 1062 may clamp the ends 1022, 1024 therebetween, asdescribed above. With the ends 1022, 1024 clamped with in the tensioningtube 1046, the tensioning tube 1046 can be rotated in a clockwisedirection (relative to the view shown in FIG. 42) to twist the ends1022, 1024 of the band 1014 (as shown in FIG. 44). Continued twisting ofthe band 1014 may tighten the band 1014 around the bone portions 12 a,12 b and drawn the bone portions 12 a, 12 b together.

With the band 1014 tensioned to a desired amount, the fasteners 1021 canbe driven through the apertures 1019 in the bracket 1016 and into thebone portions 12 a, 12 b, thereby fixing the bracket 1016 to the boneportions 12 a, 12 b and securing the bone portions 12 a, 12 b relativeto each other. Thereafter, the clamping members 1062 can be threadedback away from each other to release the ends 1022, 1024 of the band1014, and the tensioning device 1018 can be removed from the bracket1016. Thereafter, the ends 1022, 1024 can be trimmed and tied to eachother, as shown in FIG. 45.

With reference to FIGS. 46-50, another closure system 1110 is provided.The system 1110 may include a band 1114, a bracket 1116 and a tensioningdevice 1118. The band 1114 can be similar or identical to any of thebands described herein. The bracket 1116 may a plurality of mountingapertures 1117, a loop 1119, and a fastening aperture 1121. As shown inFIG. 50, fasteners 1123 may be driven through the mounting apertures1117 to secure the bracket 1116 to the patient's bone 12. A first end1122 of the band 1114 may be stitched or otherwise attached to the loop1119. A second end 1124 of the band 1114 may be attached to the bracket1116 by a fastener 1125 that extends through the fastening aperture 1121(FIG. 49), as will be subsequently described.

The tensioning device 1118 may include a base 1144 and a tensioning bolt1146. The base 1144 may be mounted over and/or on the bracket 1116 andmay include tabs 1145 that clip onto the bracket 1116. The base 1144 mayinclude a central portion 1147 having a first and second apertures 1148,1149 extending therethrough. The tensioning bolt 1146 may threadablyengage the first aperture 1148. The central portion 1147 may alsoinclude a generally U-shaped recess 1162 adjacent the first aperture 148that may guide the band 1114 33 toward the tensioning bolt 1146 beforeand during the process of tensioning the band 1114 around the patient'ssternum 12. In some embodiments, the Li-shaped recess 1162 may include aplurality of spikes (not shown) that may engage the band 1114 topre-lock the band 1114 before, during and/or after tensioning of theband 1114.

The second aperture 1149 in the base 1144 may be substantially axiallyaligned with the fastening aperture 1121 in the bracket 1116. The secondaperture 1149 may receive the fastener 1125 and a driver-bit 1150. Thedriver-bit 1150 may include a body 1151 and a tip 1152. The body 1151may include a socket 1153 adapted to receive a wrench or driver shaft(not shown). A friction ring 1154 (FIG. 48) may engage the body 1151 (orthe friction ring 1154 may be integrally formed with the body 1151) andmay slidably engage the second aperture 1149. In this manner, thedriver-bit 1150 may be held in place within the second aperture 1149 bya friction fit between the second aperture 1149 and the friction ring1154. The tip 1152 of the driver-bit 1150 may engage a head of thefastener 1125 and may transmit torque to the fastener 1125 to drive thefastener through the band 1114 and the fastening aperture 1121. In someembodiments, the fastener 1125 may also engage the second aperture 1149by a friction fit. In some embodiments, the fastener 1125 may engage thetip 1152 of the driver-bit 1150 by a friction fit.

The tensioning bolt 1146 may include a threaded shaft 1156 and a head1158. The head 1158 may include one or more slots or a socket 1159 toreceive a wrench or screwdriver, for example. A slot 1160 may extendthrough the shaft 1156 and the head 1158 and may receive the second end1124 of the band 1114 therein, as shown in FIG. 47. With the second end1124 received in the slot 1160, the tensioning bolt 1146 may bethreadably rotated in the first aperture 1148, which may wrap the band1114 around the tensioning bolt 1146 and tension the band 1114 aroundthe patient's sternum 12.

After the band 1114 is sufficiently tightened around the sternum 12using the tensioning bolt 1146, the fastener 1125 may be driven throughthe band 1114 and the fastening aperture 1121 to fix the second end 1124relative to the bracket 1116. The fastener 1125 may threadably engagethe fastening aperture 1121 and/or the patient's bone.

As shown in FIG. 51, tensioning device 1118 may be used to tighten theband 1114 without the tensioning bolt 1146. For example, a hooked needle1164 attached to the second end 1124 of the band 1114 can be passedthrough a portion of the band 1114 between the first and second ends1122, 1124 to form a loop 1166 that can be grasped by the surgeon andpulled to tighten the band 1114 around the patient's bone prior todriving the fastener 1125 through the band 1114 and fastening aperture1121, as described above.

With reference to FIG. 52, another closure system 1210 is provided. Thesystem 1210 may include a bracket 1216 and a tensioning device 1218. Thetensioning device 1218 may be generally similar to the tensioning device1118 described above, apart from any exceptions described below and/orshown in the figures. The tensioning device 1218 may include a base 1244and a tensioning bolt 1246. As with the tensioning device 1118, thetensioning bolt 1246 may threadably engage the base 1244 and may includea slot 1260 to engage the band 1114. With the band 1114 received in theslot 1260, rotation of the tensioning bolt 1246 relative to the base1244 may tension the band 1114 around the patient's sternum 12, asdescribed above.

The base 1246 may also include a plurality of guide apertures 1270extending therethrough. The guide apertures 1270 may be configured andarranged relative to each other so that they each may be aligned with acorresponding mounting aperture 1217 of the bracket 1216. The surgeonmay use the guide apertures 1270 as guides for drilling holes in thepatient's sternum 12 and/or driving screws 1219 through the mountingapertures 1217 into the patient's sternum 12, for example.

With reference to FIGS. 53-56, another closure system 1310 is provided.The system 1310 may include a band 1314, a bracket 1316 and a tensioningdevice 1318. The tensioning device 1318 may include a base 1344, atensioning bolt 1346, and a collar 1348. The structure and function ofthe base 1344 may be generally similar to that of the base 1144described above, apart from any exceptions described below and/or shownin the figures. Therefore, similar features will not be described againin detail.

As shown in FIG. 54, in some embodiments, the base 1344 may include oneor more slots 1345 through which the surgeon may insert a 35 scalpel1347 or other blade for cutting the band 1314 once the band 1314 isfully tensioned and secured relative to the bracket 1316 by fastener1325. As shown in FIG. 55, in some embodiments, the base 1344 mayinclude a pair of tabs 1349 that may releasably engage the bracket 1316to secure the base 1344 relative to the bracket 1316 during tensioningof the band 1314. To release the tabs 1349 from the bracket 1316, thesurgeon may squeeze opposing sides 1350 of the base 1344 toward eachother and then left the base 1344 upward away from the bracket 1316. Insome embodiments, the tabs 1349 may include inwardly extending blades1352 that may cooperate to cut the band 1314 when the surgeon squeezesthe tabs 1349 together to release the base 1344 from the bracket 1316.

Referring now to FIG. 53, the tensioning bolt 1346 may include athreaded portion 1358, an unthreaded portion 1360 and a shoulder 1361.The threaded portion 1358 may threadably engage an aperture in the base1344 (similar to the tensioning bolt 1146 and aperture 1148 of the base1144 described above). The unthreaded portion 1360 may rotatably engagean aperture 1362 in the collar 1348 so that the tensioning bolt 1346 canrotate relative to the collar 1348. The collar 1348 may include a tab1359 that is slidably received in a U-shaped recess 1357 of the base1344 to restrict relative rotation between the collar 1348 and the base1344.

The collar 1348 may include a cantilevered arm 1364 having a spike 1366thereon. The surgeon may press a free end 1324 of the band 1314 onto thespike 1366 to secure the free end 1324 relative to the collar 1348. Asthe tensioning bolt 1346 is threadably rotated relative to the base 1344(e.g., with a wrench or screwdriver) in a direction that causes movementof the tensioning bolt 1346 axially upward away from the bracket 1316,the shoulder 1361 of the tensioning bolt 1346 pushes the collar 1348axially upward with the tensioning bolt 1346, thereby tensioning theband 1314 around the patient's sternum 12.

As shown in FIG. 56, in some embodiments, the collar 1348 may include apair of fins 1370 that extend downward through the bracket 1316 andengage the sternotomy in the patient's sternum 12 to position thebracket 1316 relative to the sternotomy. The fins 1370 may be retractedout of the 36 sternotomy as the collar 1348 moves axially upward withthe tensioning bolt 1346 during tensioning of the band 1314.

With reference to FIGS. 57-60, a closure system 1410 is provided thatmay include a plurality of bands 1414 and a first bracket 1416 and asecond bracket 1417. In the particular example illustrated in FIG. 57,the sternum 12 includes a first vertically extending sternotomy 13 and asecond horizontally extending sternotomy 15. The first and secondbrackets 1416, 1417 and the bands 1414 may cooperate to apply a verticaland horizontal compressive forces on the sternum 12 to close the firststernotomy 13 and the second sternotomy 15.

As shown in FIG. 57, the band 1414 engaging the first bracket 1416 mayextending through the sternum 12 (rather than around the sternum 12).This can be done by attaching any suitable needle such as needle 1420 toend 1422 of the band 1414. The needle 1420 may include a break-away base1424 that allows a hooked tip 1426 of the needle 1420 to be snapped offof the band 1414 by the surgeon after the needle 1420 is pass through oraround the sternum 12. In some embodiments, the hooked tip 1426 may becut off of the base 1424 by the surgeon using wire cutters, for example.

In some embodiments, the surgeon may use needle passer 1430 to pass theneedle 1420 through the sternum 12, as shown in FIG. 60. The needlepasser 1430 may include first and second elongated members 1432, 1434that are pivotally coupled to each other. The first and second elongatedmembers 1432, 1434 may include handle portions 1436 at one end that asurgeon may grip to pivot the elongated members 1432, 1434 relative toeach other. In this manner, distal ends 1438 of the elongated members1432, 1434 may be used to pass the needle 1420 through the sternum 1420without the surgeon having to grip the needle 1420 directly with his orher fingers.

With reference to FIG. 61, another bracket 1516 is provided that mayinclude a body 1518 and a fin 1520 extending from the body 1518. Thebody 1518 may include a first slot 1522, a pair of second slots 1524 andan aperture 1526. The first slot 1522 may engage a first end of a band(not shown). For example, the first end of the band may be loopedthrough the first slot 1522 and stitched or otherwise secured to thebracket 1516. The second slots 1524 37 may be configured to receivefasteners (not shown) that may extend therethrough to secure the bracket1516 to the patient's sternum 12. The aperture 1526 may engage anotherfastener (not shown) that secures the other end of the band to thebracket 1516 after being tensioned around the sternum 12. The fin 1520may be inserted into the sternotomy prior to tensioning the band andfastening the bracket 1516 to the sternum 12 in order to position thebracket 1516 relative to the sternotomy in a desired manner. In someembodiments, the fin 1520 may include an aperture 1530 formed therein toallow bone and/or tissue to grow through the fin 1520.

With reference to FIGS. 62 and 63, another bracket 1616 is provided thatmay include a body 1618 and a pair of fins 1620 on either side of anaperture 1622 in the body 1618. As with the bracket 1516, the fins 1620of the bracket 1616 may be inserted into the sternotomy 13 to align thebracket 1616 relative to the sternotomy 13. Thereafter, a plurality offasteners 1630 may be driven through corresponding apertures in the body1618 to secure the bracket 1616 relative to the sternum 12.

With reference to FIG. 64, another bracket 1716 is provided that may begenerally similar to the brackets 1516, 1616. The bracket 1716 mayinclude a body 1718 and a fin 1720. The body 1718 may include slots 1722that engage corresponding ends of a band 1714 that has been tensionedaround the sternum 12. As described above, the fin 1720 may be insertedinto the sternotomy 13 to align the bracket 1716 relative to thesternotomy 13.

With reference to FIGS. 65-67, another closure system 1810 is providethat may include a band 1814 and a bracket 1816. The bracket 1816 mayinclude first and second sides 1818, 1820 that are resilientlycompressible toward each other. The first side 1818 may include a firstslot 1822 that engages a first end 1824 of the band 1814. For example,the first end 1824 may be stitched around the first slot 1822.

The second side 1820 may include a second slot 1826 that slidablyreceives a second end 1828 of the band 1814. A threaded aperture 1830 inthe second side 1820 may extend into the second slot 1826. A screw 1832may threadably engage the threaded aperture 1830 and may clamp thesecond end 1828 of the band 1814 in the slot 1826 to secure the secondend 1828 38 relative to the second side 1820. The second side 1820 mayalso include a pair of arms 1834 extending therefrom. The arms 1834 mayinclude a plurality of ratchet teeth 1836.

To tension the band 1814 around the patient's sternum 12, the band 1814may be looped around the sternum 12 with the first end 1824 secured tothe first side 1818 of the bracket 1816. Then, the second end 1828 ofthe band 1814 may be inserted through the second slot 1826 in the secondside 1820 of the bracket 1816 and pulled taught around the sternum 12.Then, the surgeon may secure the second end 1828 of the band 1814 to thebracket 1816 by clamping the second end 1828 in place using the screw1832, as described above. Then, the surgeon may squeeze the first andsecond sides 1818, 1820 of the bracket 1816 toward each other usingpliers 1838, for example. The ratchet teeth 1836 on the second side 1820may engage ratchet walls 1840 of the first side 1818 to secure the firstand second sides 1818, 1820 relative to each other. At any time afterclamping the second end 1828 of the band 1814 in the second slot 1826,any access length of the second end 1828 may be trimmed, as desired.

With reference to FIGS. 68-70, another closure system 1910 and method ofclosing the sternum 12 are provided. The closure system 1910 may includea band 1914 and a pair of brackets 1916. The band 1914 may be a closedloop (i.e., a continuous loop). The brackets 1916 may be plates having apair of apertures 1920 extending therethrough. As will be subsequentlydescribed, the brackets 1916 may engage corresponding ends 1922 of theclosed-loop band 1914 and may be secured to the sternum 12 by fasteners1924 that are driven through the apertures 1920.

To close the sternum 12 using the closure system 1910, the surgeon mayfirst drill a holes 1950 in each of the portions 12 a, 12 b of thesternum 12. Then, the band 1914 may be passed into one of the holes 1950in the sternum 12 and out of the other hole 1950 so that both ends 1922of the band 1914 are exposed outside of the sternum 12, as shown in FIG.68. Thereafter, the brackets 1916 may be inserted through the loopsformed between the ends 1922 of the band 1914 and the anterior surface1952 of the sternum 12. Then, the surgeon may grip the brackets 1916 andtwist the brackets 1916 in opposite directions (or hold one bracket 1916stationary while twisting the other bracket 39 1916), thereby twistingthe band 1914. Continued twisting of the band 1914 in this manner drawsthe portions 12 a, 12 b of the sternum 12 together. As shown in FIG. 70,when the sternum portions 12 a, 12 b are sufficiently drawn together,the surgeon may drive the fasteners 1924 through the apertures 1920 ofthe brackets 1916 to secure the brackets 1916 to the sternum 12.

With reference to FIGS. 71 and 72, another closure system 2010 andmethod of closing the sternum 12 are provided. The closure system 2010may include a band 2014 and a bracket 2016. The bracket 2016 may includea plate 2018 and a pair of curved arms 2020 extending partially aroundthe periphery of the plate 2018 in opposite directions. The plate 2018may be a generally circular disk and may include a central aperture 2022extending therethrough. While the aperture 2022 shown in FIGS. 71 and 72is generally heart-shaped, in other embodiments, the aperture 2022 couldbe circular or any other shape.

The arms 2020 may each include a stem 2024 extending radially outwardfrom the periphery of the plate 2018. Each arm 2020 may include firstand second ends 2026, 2028 and a body 2030 extending between the firstand second ends 2026, 2028. The stem 2024 may connect the first end 2026with the plate 2018. The second end 2028 may include a ramped surface2032. A first shoulder 2034 may be disposed between the body 2030 andthe first end 2026, and a second shoulder 2036 may be disposed betweenthe body 2030 and the second end 2028.

To close the sternum 12 using the closure system 2010, the surgeon mayfirst wrap the band 2014 around the sternum 12 and tie the ends of theband 2014 in a knot 2040, as shown in FIG. 71. Then, the bracket 2016may be placed over the knot 2040 (e.g., so that the knot 2040 and/or thesternotomy 13 are visible through the aperture 2022). Then, the bracket2016 may be rotated relative to the band 2014 about an axis extendingthrough the posterior and anterior sides of the sternum 12 so that theramped surfaces 2032 slide between the sternum 12 and the band 2014. Thesurgeon may continue to rotate the brackets 2016 until the ends of theband 2014 are received on the body 2030 of the arms 2020 between thefirst and second shoulders 2034, 2036. Sliding the arms 2020 between thesternum 12 and the band 2014 in this manner 40 may remove any remainingslack in the band 2014, thereby providing the final tensioning of theband 2014 around the sternum 12.

With reference to FIG. 73, another closure system 2110 and method ofclosing the sternum 12 are provided. The closure system 2110 may includea band 2114 and a bracket 2116. The bracket 2116 may include a plate2118 and a pair of curved legs 2120 extending partially around theperiphery of the plate 2118 in opposite directions. The plate 2118 mayinclude a central aperture 2022 extending therethrough and may have athickness that is greater than thicknesses of the legs 2120.

The legs 2120 may each include a stem 2124 extending radially outwardfrom the periphery of the plate 2118. Each leg 2120 may include firstand second ends 2126, 2028 and a body 2130 extending between the firstand second ends 2126, 2128. The stem 2124 may connect the first end 2126with the plate 2118. The second end 2128 may be spaced apart from theplate 2118. The body 2130 of each leg 2120 may include a plurality offeet 2132 extending radially outward therefrom. Each foot 2132 mayinclude an aperture 2134 through which a fastener 2036 may extend tosecure the bracket 2116 to the sternum 12. An outer periphery of thebody 2130 of each leg 2120 may include a plurality of teeth 2038.

To close the sternum 12 using the closure system 2110, the surgeon mayfirst loop the band 2114 around the sternum 12. Then, the surgeon maypass ends 2140 of the band 2114 up through the aperture 2122 partiallyaround the plate 2118 and then between the outer periphery of the plate2118 and the body 2030 of a corresponding one of the legs 2120. Then,the surgeon may drive the fasteners 2036 through the apertures 2134 andinto the sternum 12 to fix the bracket 2116 to the sternum 12 and clampthe ends 2140 of the band 2114 underneath the legs 2120.

With reference to FIGS. 74-76, another closure system 2210 and method ofclosing the sternum 12 are provided. The closure system 2210 may includea band 2214 and a bracket 2216. The bracket 2216 may include a base 2218and a flexible locking arm 2220. The base 2218 may include first andsecond ends 2222, 2224. The first end 2222 may be fixed to one end 2226of the 41 band 2214. The second end 2226 of the base 2218 may include arecess 2228 and an aperture 2230.

A first end 2232 of the locking arm 2220 may be fixed to the first end2222 of the base 2218. The locking arm 2220 may flex about the first end2232. A second end 2234 of the locking arm 2220 may be received in therecess 2228 of the base 2218. In some embodiments, the second end 2234of the locking arm 2220 may snap into engagement with the recess 2228.In some embodiments, the second end 2234 of the locking arm 2220 mayinclude a cutout 2238.

To close the sternum 12 using the closure system 2210, the surgeon mayfirst loop the band 2214 around the sternum 12. Then, the surgeon maylift the second end 2234 of the locking arm 2220 out of the recess 2228of the base 2218 and pass end 2240 of the band 2214 up through theaperture 2230 and recess 2228 of the base 2218. The surgeon may continueto pull the end 2240 of the band 2214 through the aperture 2230 andrecess 2228 until the band 2214 is sufficiently taught around thesternum 12. Thereafter, the surgeon may push the second end 2234 of thelocking arm 2220 back into the recess 2228 to lock the end 2240 of theband 2214 relative to the bracket 2216.

With reference to FIG. 77, another closure system 2310 and method ofclosing the sternum 12 are provided. The closure system 2310 may includea band 2314 and a bonding clamp 2316. The bonding clamp 2316 may includea pair of arms 2318 that are movable or resiliently flexible relative toeach other and operable to clamp first and second ends 2320, 2322 of theband 2314 therebetween. The bonding clamp 2316 may include an adhesivedispenser 2324 and one or more ultraviolet light sources 2326.

To close the sternum 12 using the closure system 2310, the surgeon mayfirst loop the band 2314 around the sternum 12. Then, the surgeon mayclamp the ends 2320, 2322 of the band 2314 between the arms 2318. Withthe ends 2320, 2322 of the band 2314 clamped between the arms 2318, thesurgeon may dispense adhesive from the adhesive dispenser 2324 onto theends 2320, 2322 of the band 2314. The surgeon may maintain the ends2320, 2322 clamped between the arms 2318 until the adhesive at leastpartially sets. The surgeon may activate the ultraviolet light sources2326, which may accelerate the 42 setting and curing of the adhesive.While the bonding clamp 2316 is described above as including one or moreultraviolet light sources 2326, additionally or alternatively, thebonding clamp 2316 could include any other suitable radiation or heatsource suitable for accelerating the setting or curing of an adhesivedispensed from the adhesive dispenser 2324.

With reference to FIGS. 78 and 79, another band 2414 is provided thatmay be used in conjunction with any of the closure systems and/ormethods described above and/or below. The band 2414 may include one ormore relatively narrow sections 2416 and one or more relatively widesections 2418. Ends 2420 of the wide sections 2418 may be tapered, asshown in FIGS. 478 and 79. Although, in some embodiments, the ends 2420may be substantially square.

Lengths of the wide sections 2418 may be any suitable length. Forexample, in some embodiments, one or more of the wide sections 2418 mayhave a length of about one inch. In some embodiments, one or more of thewide sections 2418 may have a length of about one and three-quartersinches. In some embodiments, one or more of the wide sections 2418 mayhave a width of about 0.24 inches. In some embodiments, one or more ofthe narrow sections 2416 may have a width of about 0.12 inches. In someembodiments, one or more of the wide sections 2418 may be spaced apartfrom another of the wide sections 2418 by about ten inches. It will beappreciated that the narrow and wide sections 2416, 2418 could be formedwith any suitable dimensions and any suitable spacing therebetween.

In use, the band 2414 may be wrapped around a sternum or any other boneor tissue. For example, the band 2414 aligned relative to the sternum sothat the wide sections 2418 are wrapped around lateral sides and/or aposterior side of the sternum 12. The narrow sections 2416 may be tiedin a knot or otherwise fixed relative to each other.

With reference to FIGS. 80 and 81, another closure system 2510 andmethod of closing the sternum 12 are provided. The closure system 2510may include a pair of brackets 2516 and one or more inserts 2518. Eachof the brackets 2516 may include one or more generally T-shaped slots2519 formed therein and may be fixed to the sternum 12 by a plurality offasteners 2520. The 43 inserts 2518 may be generally H-shaped bars orplates formed from a relatively rigid material and/or non-stretchablematerial. The inserts 2518 may engage the slots 2519 by a snap fit orpress fit, for example.

In use, the brackets 2516 may be fastened to the sternum 12 prior toperforming the sternotomy, as shown in FIG. 80. The brackets 2516 may befixed to the sternum 12 in positions so that the brackets 2516 arespaced apart from each other and aligned relative to each other so thatthe T-shaped slots 2519 are aligned with each other, as shown in FIG.80. After fixing the brackets 2516 to the sternum 12, the surgeon mayperform the sternotomy and perform a surgical procedure (e.g., heartsurgery). After the surgical procedure is complete, the surgeon maymanually close the sternum 12 and hold the portions 12 a, 12 b of thesternum 12 in place while inserts 2518 are placed in the T-shaped slots2519 of the brackets 2516. That is, each insert 2519 may engage thealigned slots 2519 of both of the brackets 2516, as shown in FIG. 81.Thereafter, the inserts 2518 may securely fix the brackets 2516 relativeto each other, thereby maintaining the portions 12 a, 12 b of thesternum 12 together.

With reference to FIGS. 82-84, another closure system 2610 and method ofclosing the sternum 12 are provided. The closure system 2610 may includea band 2614 and forceps 2616. The forceps 2616 may include a pair ofarms 2618 that are pivotably coupled relative to each other. Each arm2618 may include a gripping end 2620 and a clamping end 2622. Theclamping end 2622 of each arm 2618 may include a heating element 2624.The heating elements 2624 may be in electrical communication with aswitch 2626 and a removable battery 2628 attached to one of the arms2618 at or near the gripping end 2620. The heating elements 2624 mayproduce heat when provided with electrical current from the battery2628. The switch 2626 may be actuated to selectively prevent and allowthe flow of electrical current to the heating elements 2624.

To close the sternum 12 using the closure system 2610, the surgeon mayfirst loop the band 2614 around the sternum 12. Then, the surgeon mayclamp the ends 2630, 2632 of the band 2614 between the clamping ends2622 of the forceps 2616. With the ends 2630, 2632 of the band 2614clamped between the clamping ends 2622, the surgeon may actuate theswitch 2626 to 44 allow electrical current to flow through the heatingelements 2622. The surgeon may continue to clamp and apply heat to ends2630, 2632 of the band 2614 until the ends 2630, 2632 are fusedtogether. Thereafter, the surgeon may remove the forceps 2616 from theends 2630, 2632 of the band 2614. As shown in FIG. 83, any access lengthof the ends 2630, 2632 of the band 2614 may be trimmed off using ascalpel, scissors, wire cutter or any other suitable cutting device. Asshown in FIG. 84, the remaining fused ends 2630, 2632 may be bent orfolded flat.

With reference to FIGS. 85 through 91, closure systems 2810 a (FIGS. 85and 86), 2810 b (FIGS. 85 and 87), 2810 c (FIGS. 85 and 88) areprovided. Each system 2810 a, 2810 b, 2810 c may include a cerclage orband 2814, a tensioning device 2818 a, 2818 b, 2818 c, respectively, anda crimp element 2820. The band 2814 may be substantially identical tothe band 14, though it is also contemplated that the band 2814 may be aflat, elongated and flexible member formed from a braided cloth orsimilar material. In one configuration, the system 2810 may only includethe band 2814 and the tensioning device 2818, wherein the band 2814 andthe tensioning device 2818 bind at least two parts of the sternum 12together.

With reference to FIGS. 85 and 88, in a first configuration, thetensioning device 2818 a may include a male portion 2822, a femaleportion 2824, and an adjustment mechanism 2826. The male portion 2822may be fixed to a first end 2828 of the band 2814 and may include afirst arm 2830, a second arm 2832 and a guide element 2834. The guideelement 2834 may be located between and substantially parallel to thefirst arm 2830 and the second arm 2832. The first arm 2830 may besubstantially identical to the second arm 2832, and include a lockingelement or flanged portion 2833 at a distal end thereof.

The female portion 2824 of the tensioning device 2818 a may be slidablycoupled to a second end 2836 of the band 2814 and may include a firstaperture 2836, a second aperture 2838, and an opening 2840. The maleportion 2822 may be coupled to the female portion 2824 within theopening 2840, such that the flanged portions 2833 are disposed andsecured within the first and second apertures 2836, 2838.

The adjustment mechanism 2826 of the tensioning device 2818 a may beintegrally formed with, or coupled to, the male portion 2822 or thefemale portion 2824 and slidably coupled to the band 2814. Theadjustment mechanism 2826 may include a substantially rectangular frame2842 and a substantially linear cross member 2844. The cross member 2844may intersect the frame 2842, thereby forming a first aperture 2846 anda second aperture 2848. The band 2814 may be disposed within the firstaperture 2846 and the second aperture 2848, and around the cross member2844, such that the adjustment mechanism 2826 can be moved relative tothe band 2814 to increase or decrease the distance between the maleportion 2822 and the female portion 2824 of the tensioning device 2818a.

With reference to FIGS. 85 and 87, in a second configuration, thetensioning device 2818 b may include a longitudinally extending opening2843, at least one slot 2845, a rod or pin element 2847, and a claspmember 2849. The slot 2845 may be substantially L-shaped. The pinelement 2847 may be may be slidably or rotatably located within theopening 2845. The clasp member 2849 may be pivotably coupled to thetensioning device 2818 b. The first end 2828 of the band 2814 may besecured between the clasp member 2849 and the tensioning device 2818 bby rotating the clasp member 2849 relative to the tensioning device 2818b. The second end 2836 of the band 2814 may be secured between the pinelement 2847 and the tensioning device 2818 b by moving the pin element2847 through the slot 2845. In this regard, pulling the second end 2836of the band 2814 to the right (relative to the view shown in FIG. 87)may cause the pin element 2847 to move within the slot 2845 to securethe band 2814 between the pin element and the tensioning device 2818 b,and thereby secure the closure system 2810 b around the sternum.

With reference to FIGS. 85 and 86, in a third configuration, thetensioning device 2818 c may include a side beam portions 2851 a, 2851 band first, second and third cross beam portions 2853 a, 2853 b, 2853 c.The side beam portions 2851 a, 2851 b and the first and second crossbeam portions 2853 a, 2853 b may define a first opening 2855. The sidebeam portions 2851 a, 2851 b and the second and third cross beamportions 2853 b, 2853 c may define a second opening 2857. The first end2828 of the band 2814 may be secured to the first 46 cross beam portion2853 a. The second end 2836 of the band 2814 may be extended through theopening 2857 in a first direction and through the opening 2855 in asecond direction, opposite the first direction, to secure the second end2836 of the band 2814 to the tensioning device 2818 c.

With reference to FIGS. 89 through 91, the crimp element 2820 may be acylindrical or tubular-shaped construct, and may include a plurality ofteeth 2850. While the crimp element 2820 is shown as a tubular-shapedcrimping device, it is also contemplated that the crimp element 2820 mayinclude other shapes, including a U-shape. The teeth 2850 may be fixedto, or integrally formed with, an inner wall 2856 of the crimp element2820. The tips 2854 may be offset such that the band 2814 can be slidthrough the crimp element 2820 (FIG. 89). Once the band 2814 has beenpositioned within the crimp element 2820, pliers (not shown) or anothersuitable crimping device may be used to compress the crimp element 2820and force the teeth 2850 into engagement with the band 2814 (FIG. 90),thus preventing the band from moving relative to the crimp element 2820.

With reference to FIG. 91, in another configuration, teeth 2850 a mayextend from an inner wall 2856 a of a crimp element 2820 a at an anglea. The angle a may be between 15 degrees and 75 degrees. In one exampleconfiguration, the angle α is approximately 65 degrees. The angle α ofteeth 2850 a may allow the band 2814 to move relative to the crimpelement 2820 a in a first direction (e.g., to tighten the band 2814around the sternum 12), and prevent the band 2814 from moving relativeto the crimp element 2820 a in a second direction (e.g., to loosen theband 2814 around the sternum 12).

With reference to FIG. 92, another configuration of a band 2914 isshown. The band 2914 may include a plurality of slots 2926 extendingalong the length thereof. The slot 2926 may be defined by a first sidewall 2976, a second side wall 2978, a first end wall 2980, a second endwall 2982, a first arcuate corner 2984, and a second arcuate corner2986. The first side wall 2976 may extend between the first end wall2980 and the first arcuate corner 2984. The second side wall 2978 mayextend between the first end wall 2980 and the second arcuate corner2986. The first side wall 2976 may be substantially parallel to thesecond side wall 2978. In one configuration, the first side wall 2976 is47 approximately 0.014 inches longer than the second side wall 2978. Thesecond end wall 2982 may extend between the first arcuate corner 2984and the second arcuate corner 2986. The second end wall 2982 may form anangle 13 with the second side wall 2978. In one configuration, the angle13 may be approximately 99 degrees. The first end wall 2980 may besubstantially arcuate-shaped and have a radius of curvature ofapproximately 0.104 inches.

With reference to FIG. 93, another configuration of a band 3014 isshown. The band 3014 may include a first portion 3016 and a secondportion 3018. The first portion 3016 may have a substantiallyrectangular cross section, and have a width W1. The second portion 3018may have a substantially rectangular cross section, and have a width W2.The ratio of the width W2 to the width W1 may be between one and two. Inone configuration, the ratio of the width W2 to the width W1 may besubstantially equal to one and fourteen hundredths. The second portion3018 may include a plurality of slots 3026 extending along the lengththereof. The slots 3026 may be substantially semi-circular shaped anddefined by an arcuate wall 3076, a linear wall 3078, and a beveled edge3080. The arcuate wall 3076 may have a radius of curvature of 0.04-0.06inch. In one configuration, the radius of curvature of the arcuate wall3076 may be approximately 0.045 inch. The length of the linear wall 3078may be 0.05-0.07 inch. In one configuration, the length of the linearwall 3078 may be 0.063 inch. The linear wall 3078 may form an angle owith an edge 3082 of the band 3014. The angle o may be between 70degrees and 88 degrees.

With reference to FIG. 94, another configuration of a band 3114 and aneedle 3120 are shown. The band 3114 may be substantially similar to theband 14, or any of the other bands described herein. The needle 3120 maybe used in conjunction with any of the closure systems and/or methodsdescribed herein. The needle 3120 may include a base portion 3122 and atip portion 3124. The base portion 3122 may be integrally formed withthe tip portion 3124. The base portion 3120 may be fastened to a band3114 by welding, screwing, riveting, or other similar fastening methods.In this regard, the base portion 3120 may include at least one aperture3125 for fastening the needle 3120 to the band 3114. The tip portion3124 may include a proximal end 3126 and a distal end 3128. In oneconfiguration, the needle 3120 may extend in an arcuate manner betweenthe 48 proximal end 3126 and the distal end 3128. The arcuate shape ofthe needle 3120 allows the user to direct the needle in an appropriatedirection, including around the sternum 12, without causing damage toany surrounding material or tissue. The width of the distal end 3128 maybe substantially less than the width of the proximal end 3126, such thatthe needle 3120 forms a point at the distal end 3128.

With reference to FIG. 95, another configuration of a band 3214 and aneedle 3220 are shown. The band 3214 may be substantially similar to theband 14, or any of the other bands described herein. The needle 3220 mayextend in an arcuate manner from a proximal end 3222 to a distal end3224. The width of the distal end 3224 may be substantially less thanthe width of the proximal end 3222, such that the needle 3220 forms apoint at the distal end 3224 thereof. A longitudinal bore or slot 3226may be formed in the proximal end 3222 of the needle 3220. A portion ofthe needle 3220 may form a longitudinally extending lip or flangedportion 3228 along a length of the slot 3226, such that the band 14 isvisible within the slot 3226. The width of the slot 3226 may besubstantially equal to, or slightly larger than, the width of the band14, such that the band 14 slides within the slot 3226. In an assembledconfiguration, the flanged portion 3228 of the needle 3220 may becrimped or otherwise bent in the direction of the band 3214, such thatthe band is secured within the slot 3226.

With reference to FIGS. 96 through 99, another configuration of a needle3320 is shown. The needle 3320 may be used in conjunction with any ofthe closure systems described herein. The needle 3320 may include a baseportion 3322, an intermediate portion 3324, and a tip portion 3326. Withreference to FIGS. 101 through 103, in one configuration, a needle 3320a only includes a tip portion 3326. The base portion 3322, theintermediate portion 3324, and the tip portion 3326 may be integrallyformed. The base portion 3322 may include a proximal end 3328, a distalend 3330, and a slot 3332 extending from the proximal end 3328 to thedistal end 3330. The dimensions of the slot 3332 and the dimensions of aband (not shown) may be such that the band slides within the slot 3332,and frictionally engages a peripheral surface 3333 of the slot 3332 tosecure the band therein. The intermediate portion 3324 may include aproximal end 3334 and a distal end 3336. The proximal end 3334 of theintermediate portion 3324 may be wider than the distal end 3328 of theintermediate portion 3324. In this regard, the intermediate portion 3324may be tapered between the proximal end 3334 and the distal end 3336.

The tip portion 3326 of the needle 3320 may extend in an arcuate mannerfrom a proximal end 3340 to a distal end 3342. In one configuration, thetip portion 3326 may have a generally circular cross section (FIGS. 96through 99). It will be appreciated, however, that the cross section ofthe tip portion 3326 may have other shapes within the scope of thepresent disclosure. With reference to FIGS. 104 through 107, a needle3320 b is shown. The needle 3320 b may be substantially similar to theneedle 3320, except as otherwise provided herein. The needle 3320 b mayinclude a tip portion 3326 b having a substantially rectangular crosssection. The tip portion 3326 or 3326 b may have a radius of curvatureof approximately 0.708-0.735 inch. The cross sectional area of thedistal end 3342 or 3342 b of the tip portion 3326 or 3326 b may besubstantially less than the diameter of the proximal end 3340, such thatthe tip portion 3326 or 3326 b forms a point at the distal end 3342 or3342 b thereof. As illustrated in FIGS. 96 through 99, the tip portion3326 may further include at least one beveled surface 3344 extendingfrom the distal end 3342. The length L1 of the beveled surface 3344 maybe approximately 0.37-0.39 inch. With reference to FIGS. 104 through107, in one configuration the tip portion 3326 b of the needle 3320 bmay include four beveled surfaces 3344 b.

With reference to FIGS. 108 through 110, another configuration of abracket 3416 is shown. Except as otherwise provided herein, the bracket3416 may be substantially similar to the bracket 16, and may be used inconjunction with any of the closure systems described herein. Thebracket 3416 may include a body portion 3430 and a plurality of lobes3432 extending outward from the body portion 3430. The body portion 3430may include a central aperture 3434 extending therethrough. The aperture3434 may allow the bracket 3416 to be readily flexed or bent to allowfor optimal positioning of the bracket 3416 relative to the sternum 12.The aperture 3434 may also allow the bracket 3416 to be cut using bandcutters in case the sternum 12 needs to reopened after installation ofthe closure system. Each of the lobes 3432 may include one or moreapertures 3440 a, 3440 b extending therethrough. At least one of the 50apertures 3440 a may include threads 3436 for receiving a threadedfastener (not shown) that may threadably engage the sternum 12 andthereby fix the bracket 3416 to the sternum. At least two of theapertures 3440 b, located on opposite sides of the bracket 3416, mayslidably receive a band 3414 for securing the bracket 3416 to thesternum 12. The band 3414 may be a wire, a string, a polymeric band, orsimilar biocompatible flexible element that can be slidably receivedwithin the aperture 3440 b. As illustrated, in one configuration, thebracket 3416 includes four apertures 3440 a and two apertures 3440 b.The apertures 3440 b may be any suitable shape, including, but notlimited to, a circle (FIG. 108), an oval/ellipse (FIG. 109), or asquare.

With reference to FIG. 111, another configuration of a bracket 3516 isshown. The bracket 3516 may be relatively flexible to enable the bracket3516 to conform to the contours of the sternum (not shown) when thebracket 3516 is fastened thereto. The bracket 3516 may be any suitableshape, including, but not limited to, a circle, a square, anoval/ellipse (FIG. 111), and include a central portion 3518 extendingbetween end portions 3520. With reference to FIG. 112, in oneconfiguration, a bracket 3516 a may include a central portion 3518 athat is generally narrower than opposed end portions 3520 a. Thenarrower central portion 3518 a of the bracket 3516 a shown in FIG. 112may allow the bracket 3516 a to be readily flexed or bent to allow foroptimal positioning of the bracket 3516 a relative to the sternum.

The brackets 3516, 3516 a may include at least two apertures 3522 and achannel or groove 3524. The apertures 3522 may be located near oradjacent to the end portions 3520, 3520 a to assist with properlysecuring the bracket 3516, 3516 a to the sternum. The groove 3524 mayextend between and connect the apertures 3522. A band (not shown), orother suitable flexible element such as a wire, a string, or a cable,may be threaded through the apertures 3522 and positioned within thegroove 3524. The depth of the groove 3524 may be such that the band,when located within the groove 3524, does not extend above an outersurface 3526, 3526 a of the bracket 3516, 3516 a. In this regard, it isalso understood that a portion of the groove 3524 may extend through thebracket 3516 to form an oblong aperture (not shown). In addition toensuring proper positioning (for example, centering) of the band 3514between the 51 apertures 3522, the groove 3524 and/or aperture (notshown) may help to ensure that the bracket 3516 is relatively flexible,thus enabling the bracket 3516 to conform to the contours of the sternumwhen the bracket 3516 is fastened thereto. The groove 3524 and/oraperture (not shown) may also help to ensure that the bracket 3516 isable to be readily cut in case the sternum needs to reopened afterinstallation of the system 10.

With reference to FIGS. 113 and 114, another closure system 3610 isshown. The closure system 3610 may include a band 3614 and a bracket3616. The band 3614 may be a round or flat, elongated and flexiblemember formed from a metallic material and/or a polymeric material. Inone configuration, the band 3614 is a wire having a circular crosssection. The bracket 3616 may be substantially similar to the bracket16, except as otherwise described herein.

The bracket 3616 may include a body portion 3630 and at least two arms3632. The arms 3632 may extend outward from the body portion 3630, andmay include one or more apertures 3640, a channel or groove 3618, and acentral opening 3634. The channel or groove 3618 may extend between theaperture 3640 and the central opening 3634. The length of the arms 3632,and the location of the apertures 3640 with respect thereto, may be suchthat when the system 3610 is attached to the sternum 12, the location ofa force that the band 3614 imparts on the sternum 12 is adjusted by thearms 3632 and the apertures 3640. By adjusting the location of the forcethat the band 3614 imparts on the sternum 12, the bracket 3616 is ableto reduce the likelihood that the band 3614 will cut through, orotherwise damage, the sternum 12.

With continued reference to FIGS. 113 and 114, a method will bedescribed for attaching the system 3610 to the sternum 12 and tensioningthe band 3614 to reapproximate the sternum 12. The band 3614 may beinserted through the apertures 3640 a and looped around the posteriorside of the sternum 12 so that the band 3614 substantially circumscribesthe sternum 12. Once the band 3614 is looped around the sternum 12, aportion of the band 3614 may be positioned or disposed within the groove3618, and the band 3614 may be tensioned by twisting, crimping, orotherwise securing a first end 3622 of the band 3614 to a second end3624 of the band 3614. Positioning the band 3614 within 52 the groove3618 may help to contain the band 3614 and ensure that the band 3614remains centered with respect to the arms 3632 a. As shown in FIG. 113,the bracket 3616 may be positioned so that the fracture separating thetwo portions 12 a, 12 b of the sternum 12 is visible in the opening 3634in the bracket 3616 (i.e., so that two of the legs 3632 of the bracket3616 are aligned with one portion 12 a or 12 b of the sternum 12 and theother two legs 3632 are aligned with the other portion 12 a or 12 b ofthe sternum 12).

With reference to FIG. 115A, another closure system 3710 is providedthat may be used to reapproximate the sternum, or other bone, after amedical procedure. The closure system 3710 may include a chain or band3714, a bracket 3716, and a tensioning device 3718.

The band 3714 may include a plurality of links 3720 that are pivotallymounted to each other or to the bracket 3716. Each link 3720 may includea tongue portion 3722 and a base portion 3724. The tongue portion 3722may be substantially U-shaped and may include a plurality of ratchetingfins or teeth 3726 and an aperture 3728 extending therethrough. Theteeth 3726 may extend from a first side 3727 of the link 3720. While thetongue portion 3722 is shown to include three teeth 3726, it isunderstood that the tongue 3726 may include more or fewer teeth 3726within the scope of the present disclosure. It is also understood thatthe link 3720 may include more than one tongue portion 3722. Forexample, with reference to FIG. 1158, in one configuration, a link 3720a includes two tongue portions 3722 a.

As illustrated in FIG. 115A, the base portion 3724 may include a channel3730, an aperture 3732, and a tooth portion 3726 a. With reference toFIG. 1158, it is also understood that the base portion 3724 may includemore than one channel 3730 a, corresponding to the number of tongueportions 3722 a. The channel 3730 or 3730 a may receive the U-shapedtongue portion 3722 or 3722 a, respectively, such that the aperture 3728is substantially aligned with the aperture 3732. A pin 3734 may bemounted within the aperture 3728 and the aperture 3732 such that thetongue portion 3722 of the link 3720 is pivotably supported by the baseportion 3724 of an adjacent link 3720. The tooth portion 3726 a mayextend from the first side 3727 of the link 3720. The tooth portion 3726a may be of a similar size and shape as the teeth 3726, such that, whenthe 53 tongue portion 3722 is pivotably supported by the base portion3724, the tooth portion 3726 a is adjacent to, and substantially alignedwith, the teeth 3726.

The bracket 3716 may be a plate formed from a metallic and/or polymericmaterial and may include a body portion 3736 and a tongue portion 3738.The bracket 3716 may be relatively flexible to enable the bracket 3716to conform to the contours of the sternum 12 when the bracket 3716 isfastened thereto. The thickness of the body portion 3736 may be lessthan the thickness of the tongue portion 3738 to allow the bracket 3716to be readily cut using band cutters, for example, or other standardoperating room tools in case the sternum 12 needs to reopened afterinstallation of the system 3710. The tongue portion 3738 may be of asimilar size and shape as the tongue portion 3722 of the link 3720 andmay include an aperture (not shown) extending therethrough. The channel3730 of the base portion 3724 may receive the tongue portion 3738 of thebracket 3716, such that the aperture of the bracket 3716 issubstantially aligned with the aperture 3732 of the base portion 3724.The pin 3734 may be mounted within the aperture of the bracket 3716 andthe aperture 3732 of the base portion 3724 such that the tongue portion3738 of the bracket 3716 is pivotably supported by the base portion 3724of the link 3720.

With reference to FIG. 116, another configuration of a bracket 3716 a isshown. The bracket 3716 a may be substantially similar to the bracket3716, except as otherwise provided herein. The bracket 3716 a mayinclude a body portion 3736 a. The body portion 3736 a of the bracket3716 a may include a plurality of legs 3732 a extending therefrom. Eachleg 3732 a may include an aperture 3740 a therethrough. Mechanicalfasteners (not shown) may extend through the apertures 3740 a and maythreadably engage the sternum 12 to fix the bracket 3716 a to thesternum 12.

The tensioning device 3718 may include a receiver 3744 and at least oneratcheting arm 3746. The tensioning device 3718 may be integrally formedwith the bracket 3716 and extend substantially perpendicularly therefromin a substantially L-shaped configuration with the bracket 3716. Thereceiver 3744 may include an aperture 3748 extending therethrough. Theaperture 3748 may be of a similar size and shape as the base portion3724 of the link 3720, such that the links 3720 slide within theaperture 3748. In one configuration the 54 ratcheting arm 3746 mayextend from a first side 3756 of the tensioning device 3718. A first end3750 of the ratcheting arm 3746 may be integrally formed with thereceiver 3744, while a second end 3752 of the ratcheting arm 3746 mayextend at least partially into the aperture 3748. The second end 3752 ofthe ratcheting arm 3746 may engage the tooth portion 3726 a and theteeth 3726 as the band 3714 slides within the aperture 3748, therebyallowing the band 3714 to slide in a first direction within the aperture3748 and preventing the band 3714 from sliding in a second direction(opposite the first direction) within the aperture 3748.

With reference to FIGS. 117 and 118, another configuration of a closuresystem 3710 b is shown. The closure system 3710 b may include a band3714 b and a tensioning device 3718 b. The band 3714 b and thetensioning device 3718 b may be substantially similar to the band 3714and the tensioning device 3718, except as otherwise provided herein. Theband 3714 b may include a plurality of links 3720 b having teeth 3726 b.Teeth 3726 b may be formed on a second side 3729 b and/or a third side3729 b of a link 3720 b. The second side 3729 b and the third side 3729b may each be substantially perpendicular to a first side 3727 b. Theteeth 3726 b on the second side 3729 b may be asymmetrically located, oroffset, relative to the teeth 3726 b on the third side 3729 b to providefor a smaller or finer ratcheting increment, as described below. Thesecond side 3729 b may be generally parallel to the third side 3729 b.

The tensioning device 3718 b may include ratcheting arms 3746 bextending from opposed sidewalls 3756 b of the tensioning device 3718 b.The sidewalls 3756 b may be generally perpendicular to the sternum 12.The ratcheting arms 3746 b may engage the teeth 3726 b formed onsidewalls 3729 b of a base portion 3724 b of the link 3720 b, therebyallowing the band 3714 b to slide in a first direction within anaperture 3748 b of the tensioning device 3718 b and preventing the bandfrom sliding in a second direction (opposite the first direction) withinthe aperture 3748 b.

With reference to FIG. 119, another configuration of a closure system3710 c is shown. The closure system 3710 c may include a band 3714 c, abracket 3716 c and a tensioning device 3718 c. The bracket 3716 c andthe tensioning device 3718 c may be substantially similar to the bracket3716 and the 55 tensioning device 3718, except as otherwise providedherein. The band 3714 c may include alternating first portions 3715 cand second portions 3717 c. The first portions 3715 c may be thinnerthan the second portions 3717 c to allow for easier cutting of the band3714 c to an appropriate length after positioning the band 3714 c aroundthe sternum 12. The first portions 3715 c may substantially definesymmetrically displaced channels along the length of the band 3714 c. Adistal end 3731 c of the band 3714 c may include a needle portion 3733c. The needle portion 3733 c may be arcuately-shaped and pivotablycoupled to the band 3714 c. In other configurations, the needle portion3733 c may be integrally-formed with the band 3714 c. The needle portion3733 c may allow for easier insertion of the distal end 3731 c of theband 3714 c through the tensioning device 3718 c.

With reference to FIGS. 120 and 121, in another configuration atensioning device 3718 d may include a first aperture 3760 d, a secondaperture 3762 d, and a catch assembly 3764 d. The first aperture 3760 dmay be appropriately sized to receive the band 3714 therein. Alongitudinal axis 3766 d of the first aperture 3760 d may besubstantially perpendicular to a longitudinal axis 3768 d of the secondaperture 3762 d. The catch assembly 3764 d may include a base member3770 d, a biasing member 3772 d, and a tooth member 3774 d. The basemember 3770 d may be secured within the second aperture 3762 d byfriction, adhesive, or similar techniques. The biasing member 3772 d maybe a helical spring and may include a first end 3776 d fixed to the basemember 3770 d and a second end 3778 d fixed to the tooth member 3774 d.The biasing member 3772 d may be at least partially disposed within thesecond aperture 3762 d and operable to bias the tooth member 3774 d in adirection parallel to the longitudinal axis 3768 d of the secondaperture 3762 d. As the band 3714 is inserted into the first aperture3760 d, the tooth member 3774 d may engage the teeth 3726 and/or thetooth portion 3726 a to secure the band 3714 therein. The catch assembly3764 d may allow the band 3714 to move in a first direction within thefirst aperture 3760 d (parallel to the longitudinal axis 3766 d) andprevent the band 3714 from moving in a second direction (opposite thefirst direction) within the first aperture 3760 d.

With reference to FIG. 116, a method will be described for attaching thesystem 3710 to the sternum 12 and tensioning the band 3714 to 56reapproximate the sternum 12. While the method is generally describedwith respect to the system 3710, it will also be appreciated that themethod may be used with other closure systems described herein. A firstend 3754 of the band 3714 may be looped around the posterior side of thesternum 12 so that the band 3714 substantially circumscribes the sternum12. Once the band 3714 is looped around the sternum 12, the first end3754 of the band 3714 may be inserted up through the receiver 3744. Thebracket 3716 may be positioned so that the fracture separating the twoportions 12 a, 12 b of the sternum 12 is substantially adjacent to thebody portion 3736 of the bracket 3716.

The tensioning device 3718 may be used to tighten the band 3714 aroundthe sternum 12 to bind the portions 12 a, 12 b of the sternum 12together. Specifically, the first end 3754 of the band 3714 may be slid,or otherwise extended, through the receiver 3744 to tighten the band3714 around the sternum 12 to a desired amount. As the band 3714 is slidthrough the receiver 3744 in the first direction, the second end 3752 ofthe ratcheting arm 3746 may engage the tooth portion 3726 a or the teeth3726 to hold the band 3714 at the desired tightness, and prevent theband 3714 from sliding in the second direction. After the band 3714 hasbeen secured within the tensioning device 3718 at a desired tightness,excess links 3720 that extend beyond the tensioning device 3718 can beremoved by removing the pin 3734 that extends through the apertures3728, 3732 of the tongue portion 3722 and the base portion 3724,respectively.

With reference to FIG. 122, another closure system 3810 is provided thatmay be used to reapproximate the sternum, or other bone, after a medicalprocedure. The closure system 3810 may include a band 3814 and atensioning device 3818.

The band 3814 may be substantially similar to the band 3714, except asotherwise provided herein. Accordingly, like numerals will be used todescribe like features and components. With reference to FIG. 123, theband 3814 may include a locking element 3820. The locking element 3820may include a base portion 3822 and a tongue portion 3824. The baseportion 3822 may be substantially similar to the base portion 3724 ofthe link 3720. The tongue portion 3824 may include a first aperture3826, a first ratcheting arm 3828 a and a second 57 ratcheting arm 3828b. The first aperture 3826 may include a first axis 3830 thatperpendicularly intersects the sternum 12. The first ratcheting arm 3828a and the second ratcheting arm 3828 b may be flexible and generallydefine a V-shaped tongue portion 3824.

The tensioning device 3818 may include a first end 3830 and a second end3832. The first end 3830 may include a first Li-shaped channel 3833, afirst aperture 3834, and a second aperture 3836. The first Li-shapedchannel 3832 may receive the tongue portion 3722 of the link 3720, suchthat the aperture 3834 is substantially aligned with the aperture 3728.The pin 3734 may be mounted within the aperture 3728 and the aperture3834 such that the tongue portion 3722 of the link 3722 is pivotablysupported by the first end 3830 of the tensioning device 3818.

The second end 3832 of the tensioning device 3818 may include a secondLi-shaped channel 3838 opposing the first Li-shaped channel 3832 andgrooves 3840 on opposing lateral sides of the channel 3832. The grooves3840 may extend the length of the second Li-shaped channel 3838. Thechannel 3838 and the grooves 3840 may be sized to receive the lockingelement 3820. The grooves 3840 may include a plurality of teeth 3846.When the locking element 3820 is inserted into the bore 3840, the firstand second ratcheting arms 3828 a, 3828 b may engage at least one of theteeth 3846 to secure the locking element 3820 within the bore 3840. Asecond aperture 3846 may be formed between the first Li-shaped channel3832 and the second Li-shaped channel 3838. The second aperture 3846 maybe substantially parallel to the first aperture 3826, such that pliersor a similar device can be used to pull the first aperture 3826 in thedirection of the second aperture 3846 and tighten the band 3818 aroundthe sternum 12.

With reference to FIG. 124, another closure system 3910 is provided thatmay be used to reapproximate the sternum, or other bone, after a medicalprocedure. The closure system 3910 may include a band 3914, a bracket3916 and a tensioning device 3918.

The band 3914 may be substantially similar to the band 3714, except asotherwise provided herein. Accordingly, like numerals will be used todescribe like features and components.

The bracket 3916 may include a base portion 3920, a mid-portion 3922 andan end portion 3924. The base portion 3920 may be substantially similarto the base portion 3724 of the link 3720. The mid-portion 3922 may bewider than the end portion 3924. The end portion 3924 may include atleast one tooth 3926 formed on a first side 3928 thereof.

The tensioning device 3918 may include a tongue portion 3930 and areceiver 3932. The tongue portion 3930 may be substantially similar tothe tongue portion 3722 of the link 3720, such that the tongue portion3930 of the tensioning device 3918 can be rotatably mounted to the baseportion 3724 of the link 3720. The receiver 3932 may include a firstwall 3934, a second wall 3936, and a flange 3938. The flange 3938 may besubstantially parallel to the first wall 3934 and extend around theperiphery of the tensioning device 3918. The first wall 3934 may includea plurality of teeth 3940. As illustrated in FIGS. 124 and 125, as thebracket 3916 slides within the receiver 3932, the tooth 3926 may engageat least one of the plurality of teeth 3940 to prevent the bracket 3916from moving in a first direction within the receiver 3932. The flange3938 may engage the mid-portion 3922 of the bracket 3916 to prevent thebracket 3916 from moving in a second direction (perpendicular to thefirst direction) within the receiver.

With reference to FIG. 126, another configuration of a closure system4010 is provided that may be used to reapproximate the sternum, or otherbone, after a medical procedure. The closure system 4010 may include aband 4014, a receiver 4016, a link member 4018, and a nut member 4020.

The band 4014 may be substantially similar to the band 3714, except asotherwise provided herein. Accordingly, like numerals will be used todescribe like features and components.

As illustrated in FIG. 127, the receiver 4016 may include a body portion4022 having an aperture 4024 therethrough. As illustrated in FIG. 128,in another configuration, a receiver 4016 a may include a countersink4025 and a U-shaped recess 4026. The receiver 4016 may be rotatablymounted to a first end 4028 of the band 4014. The link member 4018 maybe rotatably mounted to a second end 4030 of the band 4014 and may havea diameter substantially equal to a diameter of the aperture 4024 or awidth of the U-shaped recess 4026. The link member 4018 may be anelongated rod-like member with a 59 male threaded portion 4028. Afterthe link member 4018 has been slid into the aperture 4024, the nutmember 4020 may be threaded onto the link member 4018 to secure the linkmember 4018 within the aperture 4024 and to tighten the band 4014 aroundthe sternum 12. Alternatively, the nut member 4020 may be threaded ontothe link member 4018 prior to inserting the link member 4018 into theU-shaped recess 4026. The link member 4018 may then be slid into theU-shaped recess 4026 prior to further tightening the nut member 4020onto the link member 4018 to facilitate tightening of the band 4014around the sternum 12. In a tightened configuration, the nut member 4020may be secured within the countersink 4025 of the receiver 4016.

With reference to FIG. 129, another configuration of a receiver 4116 anda link member 4118 is shown. The receiver 4116 may include at least oneslot 4120 therethrough. In one example, the receiver 4116 may includetwo slots 4120. The slots 4120 may intersect to define at least onecatch portion 4122 of the receiver 4116, therebetween. While the slots4120 are shown forming an X-shaped configuration, it will be appreciatedthat the receiver may include a plurality of intersecting slots 4120,forming variations of an asterisk or star-shaped aperture through thereceiver 4116.

The link member 4118 may be an elongated rod-like member. The linkmember 4118 may include a plurality of bumps or dimples 4124. When thelink member 4118 is inserted into the at least one slot 4120, at leastone of the catch portions 4122 of the receiver 4116 may engage at leastone of the plurality of dimples 4124 to secure the link member 4118within the receiver 4116. Accordingly, once the band 4014 has beentightened around the sternum 12 and the link member 4118 has beeninserted into the receiver 4116, the dimples 4124 and the catch portions4122 may ensure that the band 4014 remains secured around the sternum12.

With reference to FIG. 130, another configuration of a link member 4220and a bracket member 4216 are shown. The link member 4220 and bracketmember 4216 may be operatively associated with a band 4214. The band4214 can be similar or identical to any of the bands described herein.The link member 4220 may be substantially similar to the link member3720, except as otherwise provided herein. The link member 4220 mayinclude at least one 60 aperture 4222. The at least one aperture 4222may extend in a direction substantially perpendicular to the aperture3728 and the aperture 3732. The bracket member 4216 may be a plate-likemember having a first end 4224 and a second end 4226. The first end 4224may be pivotably mounted to the band 4214. The second end 4226 mayinclude at least one tooth element 4228. The at least one tooth element4228 may be integrally formed with the bracket member 4216. At least oneof the tooth elements 4228 may be received, and frictionally secured,within at least one of the apertures 4222. The tooth element 4228 andthe aperture 4222 may cooperate to secure the band 4214 around thesternum 12. Alternatively, the at least one tooth element 4228 may be aseparate piece, such as a mechanical fastener 4228 a (FIGS. 130a and130b ), extending through first and second brackets 4216 a, 4216 b, andinto the sternum 12.

With reference to FIG. 131, another configuration of a closure system4310 is provided that may be used to reapproximate the sternum, or otherbone, after a medical procedure. The closure system 4310 may include aband 4314, a receiver 4316, and a strap member 4318. The band 4314 canbe similar or identical to any of the bands described herein. Asillustrated, in one configuration, the band 4314 may be substantiallysimilar to the band 3714, except as otherwise provided herein.Accordingly, like numerals may be used to describe similar features andcomponents.

The receiver 4316 may include a base portion 4320, a tongue portion4322, and a loop element 4324. The base portion 4320 may besubstantially similar to the base portion 3724 of the link 3720. Thetongue portion 4322 may extend from the base portion 4320. The loopelement 4324 may be integrally formed with the tongue element 4322. Theloop element 4324 may be formed from a flexible and crimpable metal.

The strap member 4318 may be a substantially elongated member having afirst end 4326 and a second end 4328. The first end 4326 may bepivotably coupled to the band 4314. The second end 4328 may form apointed tip to assist with inserting the strap member 4318 through theloop element 4324. The strap member 4318 may be formed from a bendableand flexible metal, or similar material.

Once the strap member 4318 has been inserted into the loop element 4324and the band 4314 has been secured around the sternum 12 to a desiredtightness, the strap member 4318 may be secured within the loop element4324 by bending or folding the strap member 4318 at a substantially 180degree angle. The strap member 4318 may also be secured within the loopelement 4324 by crimping or otherwise bending the loop element 4324 onto the strap member 4318.

With reference to FIG. 132, another configuration of a closure system4410 is provided that may be used to reapproximate the sternum, or otherbone, after a medical procedure. The closure system 4410 may include aband 4414 and a receiver 4416.

The band 4414 can be similar or identical to any of the bands describedherein. As illustrated, in one configuration, the band 4314 may besubstantially similar to the band 3714, except as otherwise providedherein. Accordingly, like numerals may be used to describe similarfeatures and components. The band 4414 may include a plurality ofinterconnected link members 4415. The link members 4415 may besubstantially similar to the link member 4220 (FIG. 130), except asotherwise provided herein. Accordingly, like numerals will be used todescribe like features and components.

The receiver 4416 may include a tongue portion 4418 and a loop portion4420. The loop portion 4418 may be pivotably coupled to the band 4414.The loop portion 4420 may be integrally formed with the tongue portion4418 and may include a tooth element 4422. The tooth element 4422 mayextend in a radial direction relative to the loop portion 4420 and maybe received and secured within the aperture 4222.

With reference to FIG. 133, another configuration of a closure system4510 is provided that may be used to reapproximate the sternum 12, orother bone, after a medical procedure. The closure system 4510 mayinclude a band 4514 and a securing means 4516. The securing means 4516may be a wire, a string, a cable, or similar device extending throughthe aperture 3732 of one link 3724 and extending through the aperture3728 of another link 3724.

The band 4514 can be similar or identical to any of the bands describedherein. As illustrated, in one configuration, the band 4314 may be 62substantially similar to the band 3714, except as otherwise providedherein. Accordingly, like numerals may be used to describe similarfeatures and components.

The securing means 4516 may be a string, thread, wire, zip-tie, or othersimilar device. The closure system 4510 may be secured around thesternum 12 by inserting the securing means 4516 into the aperture 3728of the tongue portion 3722 and into the aperture 3732 of the baseportion 3724, and securing a first end 4518 of the securing means to asecond end 4520 of the securing means 4520 by twisting, tying, crimping,or a similarly suitable technique.

With reference to FIGS. 134 and 135, another configuration of a closuresystem 4610 is provided that may be used to reapproximate the sternum12, or other bone, after a medical procedure. The closure system 4610may include a band 4614, a strap member 4616, and a tensioning device4620.

The band 4614 can be similar or identical to any of the bands describedherein. As illustrated, in one configuration, the band 4614 may besubstantially similar to the band 3714, except as otherwise providedherein. Accordingly, like numerals may be used to describe similarfeatures and components.

The strap member 4616 may be a substantially elongated member having afirst end 4626 and a second end 4628. The first end 4626 may bepivotably coupled to the band 4614. The second end 4628 may form apointed tip to assist with inserting the strap member 4616 through thereceiver 4618.

The strap member 4616 may be a flat, elongated and flexible memberformed from a metallic material and/or a polymeric material, forexample. The strap member 4616 may include a plurality of elongatedapertures or slots 4630 formed therein.

The tensioning device 4620 may include a receiver 4631 and a tensioningscrew 4632. The receiver 4631 may be a loop member having a first end4634 pivotably coupled to the band 4614. The tensioning screw 4632 maybe may include a head portion 4636 and a stem 4638 and may be rotatablycoupled to the receiver 4631. The stem portion 4638 may include malethreaded portion and the head portion 4636 may include one or more slotsthat can receive the tip of a screwdriver. The threads of the tensioningscrew 4632 may rotate the 63 receiver 4631 such that when the tensioningscrew 4632 is rotated relative to the receiver 4631, the receiver 4631engages the slots 4630 of the strap member 4616, and the strap member4616 moves relative to, and within, the receiver 4630 based on thedirection that the tensioning screw 4632 is rotated. In this way, thestrap member 4616 and band 4614 of the closure system 4610 areoperatively tightened or loosened around the sternum 12.

With reference to FIG. 136, another configuration of a closure system4710 is provided that may be used to reapproximate the sternum, or otherbone, after a medical procedure. The closure system 4710 may include aband 4714, a locking device 4716, and a receiver 4718.

The band 4714 can be similar or identical to any of the bands describedherein. As illustrated, in one configuration, the band 4714 may besubstantially similar to the band 3714, except as otherwise providedherein. Accordingly, like numerals may be used to describe similarfeatures and components.

The locking device 4716 may extend from a first end 4720 to a second end4722 and may include a housing 4724 and a locking element 4726. Thefirst end 4720 may be pivotably coupled to the band 4714. The housing4724 may be coupled to, or integrally formed with, the second end 4722.The locking element 4726 may include a stem portion 4728 and a headportion 4730. The stem portion 4728 may be rotatably secured within thehousing 4724 for rotation about an axis 4727. The head portion 4730 maybe integrally formed with the stem portion 4728 and may have a widthextending perpendicular to the axis 4727 and a length extendingperpendicular to the axis 4727. The width of the head portion 4730 maybe greater than the length of the head portion.

The receiver 4718 may be pivotably coupled to the band 4714 and maydefine a cavity 4732 therein. The cavity 4732 may be sized to receivethe head portion 4730 of the locking element 4726, such that when thelocking element 4726 is rotated within the housing 4724, the headportion 4730 rotates within the receiver 4718 from an unlocked positionin which the head can be moved within the receiver 4718 in a directionparallel to the axis 4727, to a locked position in which the head isprevented from moving within the receiver 4718 in a 64 directionparallel to the axis 4727. In this way, the closure system 4710 can besecured around the sternum 12.

FIGS. 137 through 157 generally illustrate alternative configurations ofthe bands and links previously described herein. It will be appreciatedthat the bands and links shown in FIGS. 137 through 157 may be used withany of the closure systems of the present disclosure.

With reference to FIG. 137, a band 4814 is shown. The band 4814 mayinclude a plurality of pivotably interconnected links 4816. Each link4816 may include a body portion 4818 and at least one tooth portion4820. The tooth portion 4820 may angularly extend from the body portion4818, including a first tooth portion 4820 a extending from a first side4822 of the body portion 4818 at an acute angle relative to the firstside 4822, and a second tooth portion 4820 b extending from a the secondside 4824 (opposite the first side) of the body portion 4818 at an acuteangle relative to the second side 4824. In one configuration, two toothportions 4820 a extend from the first side 4822 of the body portion 4818and two tooth portions 4820 b extend from the second side 4824 of thebody portion 4818. It will be appreciated that the first and secondsides 4826, 4828 may include varying numbers of tooth portions 4820. Inan assembled configuration, the tooth portion 4820 a on the first side4822 will engage the tooth portion 4820 b on the second side 4824 tosecure the band 4814 around the sternum 12.

With reference to FIGS. 138 and 139, a band 4914 is shown. The band 4914may include a plurality of pivotably interconnected links 4916. Eachlink 4816 may include a hub 4918 and an aperture 4920. The hub 4918 maybe formed of a generally flexible material and integrally formed with,and extend from, the link 4916 in a first direction. The hub 4918 mayinclude a cylindrical proximal end 4922 and a cylindrical distal end4924. The distal end 4924 may include a bore 4925 extending in the firstdirection such that the distal end 4924 forms a generally hollowcylinder. The proximal end 4922 of the hub 4918 may have a diameter 01and the distal end 4924 of the hub 4918 may have a diameter 02, greaterthan the diameter 01.

The aperture 4920 may extend through the link 4916 in the firstdirection and include a countersink portion 4926. The aperture 4920 mayhave a diameter 03 and the countersink portion 4926 may have a diameter04, greater 65 than the diameter 03. The diameter 03 of the aperture4920 may be less than the diameter 02 of the distal end 4924 of the hub4918 and greater than the diameter 01 of the proximal end 4922 of thehub 4918. The diameter 04 of the countersink portion 4926 may be greaterthan the diameter 02 of the distal end 4924 of the hub 4918.

In an assembled configuration, the hub 4918 of a first link 4916 a maybe received within the aperture 4920 of a second link 4916 b. The distalend 4924 of the hub 4918 may flex or deform to the diameter 03 withinthe aperture 4920 and return to the diameter 02 within the countersinkportion 4926, such that the distal end 4924 of the hub 4918 is securedwithin the countersink portion 4926, and the second link 4916 b canpivot about the hub 4918 of the first link 4916 a.

With reference to FIG. 140, a band 5014 is shown. The band 5014 mayinclude a plurality of pivotably interconnected links 5016. Each link5016 may include a stem portion 5018 and a forked portion 5020. The stemportion 5018 may include a first segment 5022 and a second segment 5024.The first segment 5022 may be integrally formed with the forked portion5020 and extend from the forked portion 5020 in a first direction. Thesecond segment 5024 may be integrally formed with the first segment 5022and extend from the first segment 5022 in a direction generallyperpendicular to the first direction, such that the stem portion 5018 isgenerally T-shaped. The second segment 5024 may be generally cylindricalin shape having a diameter 01.

With particular reference to FIG. 141, the forked portion 5020 may beformed of a generally flexible or bendable material, and may include afirst arm 5026 a and a second arm 5026 b. The first arm 5026 a andsecond arm 5026 b may define a void 5030 therebetween. The void 5030 maybe created by machining, or otherwise removing, a portion of the forkedportion 5020. The first and second arms 5026 a, 5026 b may each includean aperture 5032 a, 5032 b, respectively, each having a diameter 02. Thediameter 02 of the apertures 5032 a, 5032 b may be greater than thediameter 01 of the second segment 5024 of the stem portion 5018.

To assemble the band 5014, the first arm 5026 a may be bent or otherwiseseparated from the second arm 5026 b, thereby increasing the general 66dimensions of the void 5030. The second segment 5024 may be insertedinto the apertures 5032 a, 5032 b. After the second segment 5024 hasbeen inserted into the apertures 5032 a, 5032 b, the first and secondarms 5026 a, 5026 b may be bent, or may otherwise resiliently return, totheir prior configuration, thereby decreasing the general dimensions ofthe void 5030 and securing the second segment 5024 within the apertures5032 a, 5032 b.

With reference to FIG. 142, a band 5114 is shown. The band 5114 mayinclude a plurality of pivotably and rotatably interconnected links5116. The links 5116 may be any suitable configuration, includingherringbone, rope, anchor, bead, etc. As illustrated in FIG. 143, in oneconfiguration, the links 5116 are formed from a spirally orhelically-wrapped wire.

With reference to FIG. 144, a portion of a band 5214 is shown. The band5214 may include a plurality of pivotably interconnected links 5216.Each link 5216 may include a stem portion 5218 and a hook portion 5220.The stem portion 5218 may include a first segment 5222 and a secondsegment 5224. The first segment 5222 and the second segment 5224 mayeach have a thickness T. The first segment 5222 may extend in a firstdirection from a proximal end 5226 to a distal end 5228 and include anaperture 5230 therethrough. The aperture 5230 may extend in a seconddirection (perpendicular to the first direction) through the firstsegment 5222.

The second segment 5224 may extend in a direction generally parallel tothe first segment 5222 from a proximal end 5236 to a distal end 5238.The proximal end 5236 of the second segment 5224 may be integrallyformed with, and offset in the second direction from, the distal end5228 of the first segment 5222. In one configuration, the proximal end5236 is offset in the second direction from the distal end 5228 adistance substantially equal to the thickness T of the first and secondsegments 5222, 5224. The second segment 5224 may include a plurality ofratcheting fins or teeth 5240 extending from the second segment 5224 inthe second direction to a distal end 5225.

The hook portion 5220 may include an elbow 5242 and an arm 5244. Theelbow 5242 may be arcuately shaped and integrally formed with the distalend 5238 of the second segment 5224. In one configuration, the elbow5242 may have an angle of curvature substantially equal to 180 degrees.The 67 arm 5244 may extend in a direction generally parallel to thefirst and second segments 5222, 5224. The arm 5244 may be integrallyformed with the elbow 5242.

To assemble the band 5214, the hook portion 5220 of a first link 5216 amay be inserted into the aperture 5230 of a second link 5216 b. It isalso contemplated that a hook portion 5220 a of the first link 5216 amay be bent in the direction of the second segment 5224 in order toprevent the aperture 5230 of the second link 5216 b from disassemblingfrom the first link 5216 a (FIGS. 144a through 144c ).

The band 5214 and the links 5216 may be operatively associated with theclosure system 3710 (FIG. 115), for example, such that the ratchetingarm 3746 ratchets with respect to the teeth 5240 when the band 5214 isinserted into the tensioning device 3718.

With reference to FIG. 145, a band 5314 is shown. The band 5314 mayinclude at least one first link 5316 a and at least one second link 5316b. Link 5316 a may be identical, and pivotably interconnected, to link5316 b. Accordingly, like reference numerals will be used to describesimilar features. The links 5316 a, 5316 b may include a first segment5318 and a second segment 5320. The first and second segments 5318, 5320may be integrally formed from a single piece of material by stamping,machining, or by another suitable manufacturing process. The first andsecond segments 5318, 5320 may generally extend arcuately from a firstlongitudinal end 5317 to a second longitudinal end 5319. The firstsegment 5318 may include an elongated aperture 5322 having a length L1in the longitudinal direction. The elongated aperture 5322 may include afirst longitudinal end portion 5324, a second longitudinal end portion5326, and a central portion 5328 disposed between the first and secondend portions 5324, 5326. The width of the first and second end portions5324, 5326 may be less than the width of the central portion 5328.

The second segment 5320 may include a leg 5330 and an arm 5332. The leg5330 and the arm 5332 may substantially define a T-shaped second segment5320. The width of the leg 5330 may be substantially equal to the widthof the first and second end portions 5324, 5326 of the aperture 5322.The length of the arm 5332 may be less than the length of the elongatedaperture 68 5322 and greater than the width of the central portion 5328of the aperture 5322. The arm 5332 may include a beveled or chamferededge 5334 extending along the length of the arm 5332. A portion of thechamfered edge 5334 may form a planar surface 5336 with the leg 5330.

With reference to FIG. 146, in an alternative configuration, the arm5332 a of the second segment 5320 a may include a first portion 5340 anda second portion 5342. The first portion 5340 may form a ninety degreeangle with the leg 5330 a. The second portion 5342 may be generallycylindrical in shape and form a T-shape with the first portion 5340 ofthe arm 5332 a.

To assemble the band 5214, the second segment 5320 of a first link 5316a may be inserted into the aperture 5322 of the first segment 5318 of asecond link 5316 b. The leg 5330 of the first link 5316 a may berotatable within the central portion 5328 of the aperture 5322 of thesecond link 5316 b, such that the first link 5316 a can be rotated intoalignment with the second link 5316 b (FIG. 145). In the assembledconfiguration, the first longitudinal end portion 5324 of the aperture5322 of the second link 5316 b may prevent the leg 5330 of the firstlink 5316 a from rotating out of alignment. Once the first link 5316 ahas been rotated into alignment with the second link 5316 b, the arm5332 of the first link 5316 a may abut the first segment 5318 of thesecond link 5316 b to prevent disassembly of the first and second links5316 a, 5316 b. In addition, in the aligned and assembled configuration,the chamfered edge 5334 of the first link 5316 a may abut the firstsegment 5318 of the second link 5316 b to create a constant angle ofcurvature between the first longitudinal end 5317 of the first link 5316a and the second longitudinal end 5319 of the second link 5316 b.

With reference to FIGS. 147 and 149, a band 5414 is shown. The band 5414may include a plurality of pivotably interconnected first links 5416 aand second links 5416 b. The first link 5416 a may be a substantiallycylindrical member and may include a generally spherical bore or socket5426 at each end thereof, defining annular rim portions 5424. The socket5426 may have a diameter D1. The second link includes two head portions5432 a and a neck portion 5433. The head portions 5432 a are generallyspherical and have a diameter D2. The neck portion 5433 is generallycylindrical and extends between and connects the head portions 5432 a.The diameter D3 of the neck portion 5433 is less than the 69 diameter D2of the head portions 5432 a. The diameter D2 of the head portions 5432 amay be less than the diameter D1 of the socket 5426.

As illustrated in FIG. 148, in another configuration, a third link 5416c may include a first segment 5418 and a second segment 5420. The thirdlink 5416 c may be substantially similar to the first link 5416 a,except as otherwise provided herein. Accordingly, like referencenumerals will be used to describe similar features. The first and secondsegments 5418, 5420 may be integrally formed from a single piece ofmaterial by stamping, machining, or by another suitable manufacturingprocess. The first segment 5418 may be substantially cylindrical andinclude a generally spherical bore or socket 5426, having a diameter 01formed in a first end thereof. The second segment 5420 may extend from afirst end 5428 to a second end 5430. The first end 5428 of the secondsegment 5420 may be adjacent to, and extend from, a second end of thefirst segment 5418. The second end 5430 of the second segment mayinclude a generally spherical ball or head portion 5432 b having adiameter 02. The diameter 02 of the head portion 5432 b may be less thanthe diameter 01 of the socket 5426.

To assemble the band 5414, the head portion 5432 a of the second link5416 b or the head portion 5432 b of the third link 5416 c can beinserted into the socket 5426 of a second link 5416 b or the socket 5426of the third link 5416 c. The annular rim 5424 of the first link 5416 aand/or the third link 5416 c may be bent or otherwise crimped inwardtoward the neck portion 5433 of the second link 5416 b or toward thesecond segment 5420 of the third link 5416 c to prevent the head portion5432 a or 5432 b, respectively, from being removed from the socket 5426.

With reference to FIGS. 150-152, a band 5514 is shown. The band 5514 mayinclude a plurality of pivotably interconnected links 5516. The links5516 may be formed from a loop of wire, or other suitable material. Thewire may have a generally circular cross section to ensure that a firstlink 5516 smoothly pivots on a second link 5516.

To assembly the band 5414, the first link 5516 is folded such that afirst portion 5518 a of the first link 5516 a overlaps a second portion5520 a of the first link 5516, substantially defining a U-shaped firstlink 5516. The second link 70 5516 is folded in the same manner as thefirst link 5516 around the first link 5516, such that the first portion5518 of the second link 5516 overlaps the second portion 5520 of thesecond link 5516, substantially defining a U-shaped second link 5516. Inthis manner, multiple links 5516 can be interconnected until the band5514 is a desirable length for reapproximating the sternum.

With reference to FIGS. 153 through 154, another configuration of aclosure system 5810 is shown. The closure system 5810 may include acerclage or band 5814 and a tensioning device 5818. The band 5814 can besimilar or identical to any of the bands described herein. Asillustrated, in one configuration, the band 5814 is a braided construct.

The tensioning device 5818 may include a first tubular portion 5820 anda second tubular portion 5822. The first tubular portion 5820 may beadjacent and substantially parallel to the second tubular portion 5822.As illustrated, in one configuration, the first tubular portion 5820 maybe integral and/or monolithically formed with the second tubular portion5822. The first tubular portion 5820 may include a first clamp portion5824 and a first flanged portion 5826. The first clamp portion 5824 maybe formed at a first end 5827 of the tensioning device 5818. The firstclamp portion 5824 and the first flanged portion 5826 may extendradially and outwardly from the first tubular portion 5820 in a firstdirection. A slot 5828 may be formed between and separate the firstclamp portion 5824 from the first flanged portion 5826. The first clampportion 5824 may include opposed outer surfaces 5830 and opposed toothedportions 5832. The opposed outer surfaces 5830 may be substantiallyparallel to each other to allow for improved clamping of the first clampportion 5824.

The second tubular portion 5822 may include a second clamp portion 5834and a second flanged portion 5836. The second clamp portion 5834 may beformed at a second end 5837 of the tensioning device 5818. The secondclamp portion 5834 and the second flanged portion 5836 may besubstantially similar to the first clamp portion 5824 and the firstflanged portion 5826, respectively, except as otherwise provided herein.Therefore, like reference numerals are used to describe similarfeatures. The second clamp portion 5834 and the second flanged portion5836 may extend radially and outwardly from the 71 second tubularportion 5822 in a second direction, opposite the first direction of thefirst clamp portion 5824 and first flanged portion 5826.

As illustrated, in an assembled configuration, an end 5838 of the band5814 may be received through the first tubular portion 5822 and anotherend 5840 of the band 5814 may be received through the second tubularportion 5824. To secure the closure system 5810, the first end 5838 maybe placed between the toothed portions 5832 of the first clamp portion5824 and pliers 5842, or a similar clamping device, may be used togenerally crimp or clamp the band 5814 between the toothed portions 5832(FIGS. 154 and 155). The other end 5840 of the band 5814 may be placedbetween the toothed portions 5832 of the second clamp portion 5826 andthe pliers 5842 may be used to generally crimp or clamp the band 5814between the toothed portions 5832.

With reference to FIG. 189, another configuration of a closure system5910 is shown. The closure system 5910 may include a first bracketmember 5916 a, a second bracket member 5916 b, and a tensioning device5917. The tensioning device 5917 may be a threaded fastener. The firstbracket member 5916 a may be a plate formed from a metallic and/orpolymeric material and may include a body portion 5930 a and a pluralityof legs 5932 extending outward from the body portion 5930 a. The bracket5916 may be relatively flexible to enable the bracket 5916 to conform tothe contours of the sternum when the bracket 5916 is fastened thereto.The body portion 5930 a may include at least two parallel stems or beams5931 extending from the body portion 5930 a, and an aperture or bore5933 extending through or into the body portion 5930 a. The bore 5933may extend in a direction substantially parallel to the beams 5931. Eachof the legs 5932 may include one or more apertures 5940 extendingtherethrough. The apertures 5940 may extend in a direction substantiallyperpendicular to the bore 5933 and the beams 5931. Self-tapping threadedfasteners (not shown) may extend through the apertures 5940 and maythreadably engage the sternum (not shown) to fix the bracket 5916 to thesternum.

The second bracket member 5916 b may be substantially similar to thefirst bracket member 5916 a, except as otherwise provided herein.Therefore, like reference numerals are used to describe similarfeatures. The second bracket member 5916 b may include a body portion5930 b. The body 72 portion 5930 b may include at least two parallelapertures 5941 extending through the body portion 5930 b. The bodyportion 5930 b may further include another aperture 5943 extendingthrough the body portion 5930 b. The aperture 5943 may be substantiallyparallel to the apertures 5941.

In an assembled configuration, the beams 5931 may be received throughthe apertures 5941. The tensioning device 5917 may be a received throughthe aperture 5943. An end 5945 of the tensioning device 5917 may bereceived by the bore 5933 in order to generally secure the tensioningdevice 5917 relative to the first bracket member 5916 a. As thetensioning device 5917 is rotated in a first direction within theaperture 5943, the second bracket member 5916 b may move along the beams5931 and away from the first bracket member 5916 a. As the tensioningdevice 5917 is rotated in a second direction within the aperture 5943,the second bracket member 5916 b may move along the beams 5931 andtoward the first bracket member 5916 a. To affect the closure of thesternum (not shown), fasteners (not shown) may extend through theapertures 5940 and into the sternum. In another configuration, a band(not shown) may be extended through the apertures 5940 and around thesternum. As the tensioning device 5917 is rotated in the seconddirection, and the second bracket member 5916 b moves toward the firstbracket member 5916 a, the fasteners and/or band may draw and bindpreviously severed portions of the sternum together.

With reference to FIGS. 157 through 159, another configuration of aclosure system 6010 is shown. The closure system 6010 may include a band6014 and a fastener assembly 6015. The band 6014 can be similar oridentical to any of the bands described herein. As illustrated, in oneconfiguration, the band 6014 is a braided construct. The band 6014 mayextend longitudinally from a first end 6022 to a second end 6024. Thefirst end 6022 of the band 6014 may include a longitudinally extendingslot or elongate aperture 6025.

The fastener assembly 6015 may include a first member 6027 and a secondmember 6029. The first member 6027 may be fixed to the second end 6024of the band 6014 with a rivet, adhesive, mechanical fastener (e.g., ascrew), or a similar fastening technique. The second member 6029 mayreceive the first member 6027. As illustrated, in one configuration thefirst member 6027 73 may be a male button or snap member and the secondmember 6029 may be a female button or snap member, or vice versa.

With reference to FIG. 158 the band 6014 may be looped around theposterior side of the sternum 12 so that the band 6014 substantiallycircumscribes and tightens around the sternum 12. With the band 6014sufficiently tightened around the sternum 12, the first member 6027 maybe positioned within the aperture 6025 and the second member 6029 may besecured to the first member 6027, thereby securing the first end 6022 ofthe band 6014 to the second end 6024. As illustrated in FIG. 159, in anassembled configuration, the band 6014 may be pinched, clamped, orotherwise secured between the first member 6027 and the second member6029 to prevent the first end 6022 of the band 6014 from moving relativeto the second end 6024 of the band.

With reference to FIGS. 160 and 161, another configuration of a closuresystem 6110 is shown. The closure system 6110 may include a strut orbracket 6116, fasteners 6118, and securing devices 6120. The bracket6116 may include a first end portion 6145, a second end 6147, and acentral portion 6149. The central portion 6149 may extend between andconnect the first end portion 6145 to the second end portion 6147, andmay be generally narrower than the first and second end portions 6145,6147. The As illustrated in FIG. 160, first and second end portions6145, 6147 may be substantially circular and each include an aperture6151 therethrough.

As illustrated, the fasteners 6118 may be self-tapping threadedfasteners, including a head portion 6153 and a stem portion 6155. Itwill also be appreciated that the fasteners 6118 may be bolts, nails, orsimilar mechanical fastener devices, within the scope of the presentdisclosure. The securing devices 6120 may be washer or nut-like members,having an aperture 6157 therethrough. As illustrated in FIG. 160, in oneconfiguration, the aperture 6157 may be a threaded aperture.

With reference to FIG. 194, in an assembled configuration, the fasteners6118 may be extended through the sternum 12, such that the head portion6153 is disposed on a first side 6159 of the sternum 12 and the stemportion 6155 extends through to a second side 6161 of the sternum 12.The first 74 side 6159 may be an anterior side of the sternum 12 and thesecond side 6161 may be a posterior side of the sternum 12. The bracket6116 may be placed adjacent the second side 6161 of the sternum 12, suchthat the stem portions 6155 of the fasteners 6118 extend through theapertures 6151. The securing devices 6120 may be placed on the stemportions 6155 of the fasteners 6118 (e.g., by threading) to secure thebracket 6116 between the securing device 6120 and the second side 6161of the sternum 12. An end 6163 of the stem portion 6155 may be brokenoff or otherwise removed such that the stem portion 6155 does not extendfrom a posterior side 6165 of the securing device 6120.

With reference to FIGS. 162 and 163, another configuration of a closuresystem 6210 is shown. The closure system 6210 may include at least onefastener 6212 and at least one securing device 6214. The at least onefastener 6212 and the at least one securing device 6214 may be may besimilar or identical to the fastener 6118 and securing device 6120described above, apart from any exceptions described below and/or shownin the figures. Therefore, similar features may not be described againin detail and will be referenced using like reference numerals.

In an assembled configuration, the fasteners 6212 may be extendedthrough the sternum 12, such that a head portion 6153 is disposed on afirst side 6259 of the sternum 12 and the stem portion 6155 extendsthrough to a second side 6261 of the sternum 12. The first side 6259 maybe a first lateral side of the sternum 12 and the second side 6261 maybe a second lateral side of the sternum 12, generally opposite the firstlateral side. The securing devices 6214 may be placed on the stemportions 6155 of the fasteners 6212 (e.g., by threading) to secure thehead portion 6155 to the first side 6259 of the sternum 12 and securethe securing device 6214 to the second side 6261 of the sternum 12, andthereby draw and bind previously severed portions of the sternum 12together. The end 6163 of the stem portion 6155 may be broken off orotherwise removed such that the stem portion 6155 does not extend from aposterior side 6165 of the securing device 6214.

With reference to FIGS. 197 through 199, another configuration of aclosure system 6310 is shown. The closure system 6310 may include a band6314 and a bracket 6316. The band 6314 can be similar or identical toany of the 75 bands described herein. As illustrated, in oneconfiguration, the band 6314 is a braided construct extending from afirst end 6322 to a second end 6324.

The bracket 6316 may include a base 6325 and a cover 6327. The cover6327 may be pivotably coupled to the base 6325 by at least one hinge(not shown). The base 6325 may include one or more apertures 6340 aextending therethrough. The cover 6327 may include one or more apertures6340 b extending therethrough. The apertures 6340 a may be substantiallyaligned with the apertures 6340 b. Self-tapping threaded fasteners 6342may extend through the apertures 6340 a and the apertures 6340 b and maythreadably engage the sternum 12 to fix the cover 6327 relative to thebase 6325 and to fix the bracket 6316 to the sternum 12.

With continued reference to FIGS. 164 through 166, a method will bedescribed for attaching the system 6310 to the sternum 12 and tensioningthe band 6314 to reapproximate the sternum 12. The first end 6322 of theband 6314 may be looped around the posterior side of the sternum 12 sothat the band 6314 substantially circumscribes the sternum 12. The firstend 6322 of the band 6314 may be received in a first end 6329 of thebracket 6316 and the second end 6324 of the band 6314 may be received ina second end 6331 of the bracket 6316, such that the first and secondends 6322, 6324 extend through the bracket 6316, substantially betweenthe base 6325 and the cover 6327. As shown in FIG. 164, the bracket 6316may be positioned so that at least one of the one or more apertures 6340a is aligned with the portion 12 a of the sternum 12, and at least oneof the one or more apertures 6340 a is aligned with the portion 12 b ofthe sternum 12. A force may be applied to the first and second ends6322, 6324 of the band 6314 to tighten the band 6314 around the sternum12 to a desired amount. Once the band 6314 has been tightened to thedesired amount, fasteners 6342 may be extended through the apertures6340 a, 6340 b to draw the cover 6327 in the direction of the base 6325,and thereby clamp or otherwise secure the band 6314 between the cover6327 and the base 6325. Extending the fasteners 6342 through theapertures 6340 a, 6340 b and into the sternum 12 may also fix thebracket 6316 to the sternum 12, as described above.

With reference to FIG. 167, in another configuration, a closure system6310 a may include a bracket 6316 a. The closure system 6310 a and the76 bracket 6316 a may be substantially similar to the closure system6310 and the bracket 6316, except as otherwise provided herein.Accordingly, like reference numerals will be used to describe similarfeatures. The bracket 6316 a may include one or more apertures 6340 a inthe base 6325 may be threaded apertures. A fastener 6342 a, including ahead portion 6343, a stem portion 6345, and a tip portion 6347, mayextend through the cover 6327 such that the head portion 6343 is locatedon a first side 6349 of the cover 6327 and the tip portion 6347 islocated on a second side 6351 of the cover 6327. The stem portion 6345may be rotatably disposed within the aperture 6340 b. The tip portion6327 may be threaded, such that it can threadingly engage the aperture6340 a in the base 6325. Once the band 6314 has been tightened to thedesired amount around the sternum 12, the tip portion 6327 of thefastener 6342 a may be extended into the aperture 6340 a to draw thecover 6327 in the direction of the base 6325, and thereby clamp orotherwise secure the band 6314 between the cover 6327 and the base 6325.

With reference to FIGS. 168 and 169, another configuration of a closuresystem 6410 is shown. The closure system 6410 may include a cerclage orband 6414, a first link or implant 6415 a, a second link or implant 6415b, a tie member 6417, a first needle member 6419 a, and a second needlemember 6419 b. The band 6414 can be similar or identical to any of thebands described herein. As illustrated, in one configuration, the band6414 is a braided construct extending from a first end 6422 to a secondend 6424. The first and second ends 6422, 6424 may define loopedportions 6425, 6427, respectively. The looped portions 6425, 6427 may beformed by folding and stitching the first and second ends 6422, 6424,respectively to the band 6414.

The first implant 6415 a may include a hook portion 6429 and a loopportion 6431. As illustrated, in one configuration, the first implant6415 a may be formed in the shape of an “e.” The second implant 6415 amay be the same as the first implant 6415 b. Therefore, like referencenumerals will be used to describe similar features.

The tie member 6417 may be a flexible member construct extending from afirst end 6433 to a second end 6435. One suitable flexible memberconstruct-type is disclosed in commonly assigned U.S. Pat. Pub. No. 772012/0053630. The disclosure of U.S. Pat. Pub. No. 2012/0053630 ishereby incorporated by reference as if fully set forth herein.

The first needle member 6419 a may be substantially rigid and extendfrom a first end 6437 to a second end 6439. The second end 6439 may becurved and generally form a hook. The second needle member 6419 b may bethe same as the first needle member 6419 a. Therefore, like referencenumerals are used to describe similar features.

Operation of the closure system 6410 will now be described in moredetail. The closure system 6410 may be utilized with an implantationtool 6441. With reference to FIG. 169, in a first configuration, thefirst end 6437 of the first needle member 6419 a may be fixed to thelooped portion 6425 of the band 6414, and the first end 6437 of thesecond needle member 6419 b may be fixed to the looped portion 6427 ofthe band 6414. The first and second needle members 6419 a, 6419 b may beused to direct the band 6414 around the sternum. The first and secondneedle members 6419 a, 6419 b may be removed from the band 6414, and thehook portion 6429 of the first and second implants 6415 a, 6415 b may beinserted through the looped portions 6425, 6427, respectively, of theband 6414. The tie member 6417 may be fixed to the loop portion 6431 ofthe first and second implants 6415 a, 6415 b.

The tool 6441 may include first arms 6443 a, 6443 b, second arms 6445 a,6445 b, and a body 6447. A first end 6449 of the first arms 6443 a, 6443b may be pivotably coupled to the body 6447. The second arms 6445 a,6445 b may extend from a first end 6451 to a second end 6453. The secondarms 6445 a, 6445 b may be pivotably coupled to the body 6447 at anelbow portion 6455. The elbow portion 6455 may be operably disposedbetween the first and 6451 and the second end 6453 of the second arms6445 a, 6445 b.

In a first configuration of the closure system 6410, a second end 6457of the first arms 6443 a, 6443 b may be coupled to the first and secondimplants 6415 a, 6415 b, respectively. The first end 6451 of the secondarms 6445 a, 6445 b may be coupled to the first and second ends 6433,6435, respectively, of the tie member 6417. The first arms 6443 a, 6443b may pivot about the first end 6449 to generally move the first implant6415 a in the direction of the second implant 6415 b, and vice versa, totighten the band 6414 around the 78 sternum. The second arms 6445 a,6445 b may pivot about the elbow portion 6455 to generally move thefirst implant 6415 a in the direction of the second implant 6415 b, andvice versa, to tighten and secure the band 6414 around the sternum.

With reference to FIGS. 170 through 172, another configuration of aclosure system 6510 is shown. The closure system 6510 may include a band6514, a first bracket 6516 a, and a second bracket 6516 b. The band 6514may be a flexible member construct, such as a string, extending from afirst end 6522 to a second end 6524.

The first bracket 6516 a may be a plate formed from a biocompatiblemetallic and/or polymeric material. The first bracket 6516 a may berelatively flexible to enable the first bracket 6516 a to conform to thecontours of the sternum 12 when the bracket 16 is fastened thereto (asshown in FIG. 170). The first bracket 6516 a may include a pluralitylaterally extending nubs 6517 and a plurality of hook members 6519. Thelaterally extending nubs 6517 may be integrally formed with the firstbracket 6516 a. Each of the nubs 6517 may include one or more apertures6540 extending therethrough. The apertures 6540 may include a chamferedor beveled edge 6541 adjacent a first or upper surface 6543 of the firstbracket 6516 a. Self-tapping threaded fasteners 6542 may extend throughthe apertures 6540 such that a head portion 6545 of the fasteners 6542is adjacent the beveled edge 6541 of the apertures 6540. The fasteners6542 may threadably engage the sternum 12 to fix the first bracket 6516a to the sternum 12 (as shown in FIG. 170). Each of the plurality ofhook members 6519 may be interposed between two adjacent nubs 6517,defining an alternating pattern of nubs 6517 and hook members 6519. Thesecond bracket 6516 b may be the same as the first bracket 6516 a.Therefore, like reference numerals will be used to describe similarfeatures.

With continued reference to FIGS. 170 through 172, a method will bedescribed for attaching the system 6510 to the sternum 12 toreapproximate the sternum 12. The first bracket 6516 a may be fixed tothe first portion 12 a of the sternum 12 with the fasteners 6542. Thesecond bracket 6516 b may be fixed to the second portion 12 b of thesternum 12 with the fasteners 6542. The band 6514 may be wrapped aroundor otherwise connected to and between the hook members 6519 on the firstbracket 6516 a and the hook members 6519 79 on the second bracket 6516b, such that the band 6514 forms at least one cross or “X” configurationbetween the first bracket 6516 a and the second bracket 6516 b. A forcemay be applied to the first and/or second end 6522, 6524 of the band6514 to urge the first bracket 6516 a in the direction of the secondbracket 6516 b, and thereby urge the first portion 12 a of the sternum12 in the direction of the second portion 12 b.

With reference to FIGS. 173 through 177, another configuration of aclosure system 6610 is shown. The closure system 6610 may include a band6614 and a bracket 6616. The band 6614 may be identical to the tiemember 6417, except as otherwise provided herein. Therefore likereference numerals will be used to describe similar features. The band6614 may include a first toggle 6619 a and a second toggle 6619 b.

The bracket 6616 may be substantially similar to the bracket 16, exceptas otherwise provided herein. Therefore, like reference numerals will beused to describe similar features. The bracket 6616 may include one ormore apertures 40 a extending therethrough and one or more nubs 6621formed on a first surface 6623 of the bracket 6616. As illustrated, inone configuration, the bracket 6616 includes two apertures 40 a disposedon opposite lateral sides of the opening 34, and first and secondannular nubs 6621 a, 6621 b (FIGS. 175 through 177) encircling each ofthe apertures 40 a. The first annular nub 6621 a may be concentric tothe second annular nub 6621 b. Threaded fasteners 42 a may extend intothe apertures 40 a from the first side 6623 such that the fasteners 42 ado not extend from a second side 6625 (opposite the first side 6621) ofthe bracket 6616. As illustrated in FIG. 177, in an assembledconfiguration, at least a portion of the band 6614 may be disposed andsecured between a head 6627 of the fasteners 42 a and the nubs 6621.

With continued reference to FIGS. 173 through 177, a method will bedescribed for attaching the system 6610 to the sternum 12 toreapproximate the sternum 12. The band 6614 may be inserted into theapertures 40 a and around the sternum 12, such that the first toggle6619 a is disposed adjacent one of the apertures 40 a and the secondtoggle 6619 b is disposed adjacent another of the apertures 40 a. Withparticular reference to FIG. 174, a force may be applied to the firstand second ends 6417 a, 6417 b of the band 6614 80 to secure the band6614 around the sternum 12 and secure the first portion 12 a of thesternum 12 relative to the second portion 12 b of the sternum 12. Withparticular reference to FIGS. 176 and 177, the threaded fasteners 42 amay extend into the apertures 40 a such that the band 6614 is disposedbetween the head 6627 of the fasteners 42 a and the nubs 6621 to securethe band 6614 around the sternum 12 and secure the first portion 12 a ofthe sternum 12 relative to the second portion 12 b of the sternum 12.With the band 6614 secured around the sternum 12 and the first portion12 a of the sternum 12 secured relative to the second portion 12 b ofthe sternum 12, the bracket 6616 may be fixed to the sternum 12 with thefasteners 6642, such that the bracket 6616 additionally secures thefirst portion 12 a of the sternum 12 secured relative to the secondportion 12 b of the sternum 12.

With reference to FIGS. 178 and 179, another configuration of a bracket6716 is shown. The bracket 6716 may be substantially similar to thebracket 6616, except as otherwise provided herein. Accordingly, likereference numerals will be used to describe similar features. Thebracket 6716 may include at least one hook portion 6718. As illustrated,in one exemplary configuration, the bracket includes two hook portions6718 disposed on opposite lateral sides of the opening 34. The hookportions 6718 may extend from the first surface 6623 of the bracket 6616such that an opening 6631 of one hook portion 6718 generally faces anopening 6631 of another hook portion 6718. The band (not shown) may becoupled to the hook portions 6718 and wrapped around the sternum 12 tosecure the band around the sternum 12 and secure the first portion 12 aof the sternum 12 relative to the second portion 12 b of the sternum 12.The bracket 6616 may be fixed to the sternum 12 with the fasteners (notshown).

FIG. 180 is a perspective view of a bone punch tool 7000 in a retractedposition, in accordance with at least one example of the presentdisclosure. The bone punch tool 7000 can include a support arm 7002having a support arm distal portion 7004 and a support arm proximalportion 7006. The bone punch tool 7000 can include a pivot arm 7008having a pivot arm distal portion 7010 and a pivot arm proximal portion7012. In at least one example, the pivot arm distal portion 7010 can bepivotably coupled to the support arm distal portion 7004 such as atpivot point 7014. In some examples, one or both of the support arm 7002and the pivot arm 7008 can include a grip 7044 so as to facilitate auser's use of the bone punch tool 7000.

The bone punch tool 7000 can include an arcuate punch 7016 having a bonepiercing tip 7018 configured to punch through a bone portion so as toform an arcuate hole therethrough. The arcuate punch 7016 can be coupledto the pivot arm distal portion 7010. In at least one example, thearcuate punch 7016 can be formed integral with the pivot arm distalportion 7010, such that the pivot arm 7008 extends from the pivot armproximal portion 7012 to the piercing tip 7018. In at least one example,the arcuate punch 7016 is curved (or arcuate) along its length.

In the illustrated example, the bone punch tool 7000 is depicted in theretracted position, with the arcuate punch 7016 retracted, and the pivotarm proximal portion 7012 a first distance 7050 from the support armproximal portion 7006. The pivot arm proximal portion 7012 can beconfigured to be moved away from the support arm proximal portion 7006(e.g., by a surgeon or other user) such as in a punch direction 7020.Movement of the pivot arm proximal portion 7012 in the punch direction7020 can cause the pivot arm distal portion 7010 to pivot about thepivot point 7014 and the arcuate punch 7016 to extend into a punchposition. In at least one example, the pivot point 7014 is positioned atthe support arm distal portion 7004 at a center of curvature of thearcuate punch 7016.

In some examples, the bone punch tool 7000 can include a protrusion 7022coupled to the support arm distal portion 7004. In at least one example,the protrusion 7022 can be configured to intercept an arc defined by thecurvature of the arcuate punch 7016. In some examples, the protrusion7022 comprises a plate. In some examples, the protrusion 7022 can beconfigured to receive the bone piercing tip 7018 of the arcuate punch7016 when the bone punch tool 7000 is in the punch position. In at leastone example, the protrusion 7022 can include a recess 7024 such as toreceive the bone piercing tip 7018.

In some examples, the bone punch tool 7000 can include a housing 7026.In at least one example, the housing 7026 can be coupled to the supportarm distal portion 7004. In at least one example, the housing 7026 caninclude a shoulder 7028 configured to engage a lip 7030 of the pivot armdistal portion 7010. In at least one example, when the shoulder 7028engages the lip 7030, the pivot arm proximal portion 7012 is preventedfrom further movement in the punch direction 7020. In some examples, thehousing 7026 can house a portion of the arcuate punch 7016. In someexamples, the housing 7026 can house the pivot point 7014.

In some examples, the housing 7026 can be formed integral with thesupport arm distal portion 7004. In at least one example, the housing7026 can be formed integral with the support arm distal portion 7004 andthe protrusion 7022. In some examples, the housing 7026 and theprotrusion 7022 together can define a receptacle 7032 configured toreceive a bone portion. In some examples, the receptacle 7032 can beu-shaped or c-shaped. In at least one example, the receptacle 7032 canbe dimensioned to receive a portion of a sternum. In at least oneexample, the receptacle 7032 can be dimensioned to receive a portion ofa manubrium. In at least one example, the housing 7026 can include awall 7036 configured to contact a cut surface of the portion of thesternum. In at least one example, the wall 7036 can align the bone punchtool 7000 relative to the cut surface of the portion of the sternum. Insome examples, the wall 7036 has a height that corresponds to athickness of a sternum. In at least one example, the height of the wall7036 is greater than the thickest cross-section region of a sternum, themanubrium. In at least one example, the height of the wall 7036 can begreater than an average greatest thickness determined from computerizedtomography (CT) scans of different patients. In at least one example,the height of the wall 7036 can accommodate any portion of a particularsternum (such that the bone punch tool 7000 can be used anywhere on thesternum). In some examples, the height of the wall 7036 can accommodatedifferent size sternums across a patient population. In at least oneexample, the height of the portion of the wall 7036 within thereceptacle 7032 can be adjustable, for example, by adjusting theprotrusion 7022. In at least one example, the height of the wall 7036can be approximately 20 millimeters (0.787 inches).

In some examples, the bone punch tool 7000 can include one or morealignment guides 7038, 7040. In some examples, the bone punch tool 7000can include a support arm alignment guide 7038 positioned on the supportarm 7002. In at least one example, the bone punch tool 7000 can includea pivot arm alignment guide 7040 positioned on the pivot arm 7008. Thealignment guide 7038, 7040 can be configured to indicate the orientationof the bone punch tool 7000 relative to an existing bone hole, apatient's anatomy, or other markers. In at least one example, thealignment guide 7038, 7040 can include one or more windows. In at leastone example, the width of the window can correspond to a width of thearcuate punch 7016.

In some examples, the bone punch tool 7000 can include a locking member7042. In at least one example, the locking member 7042 is configured tourge the pivot arm 7008 toward the support arm 7002. In some examples,the locking member 7042 can be engaged to prevent movement of the pivotarm proximal portion 7012 in the punch direction 7020. In some examples,the locking member 7042 can help prevent exposure of the bone piercingtip 7018 of the arcuate punch 7016 when the bone punch tool 7000 is notbeing used to punch a hole. In some examples, the locking member 7042can be disabled to allow the arcuate punch 7016 to move in the punchdirection 7020. In at least one example, the locking member 7042 caninclude a biasing element that can be overcome by a user applying forceto the pivot arm 7008. In at least one example, the locking member 7042can include a pin. In some examples, the locking member 7042 can includea spring that urges one or more ball bearings outward to createsufficient friction for keeping the arcuate punch 7016 in the retractedposition. In at least one example, the friction created by the lockingmember 7042 can be easily overcome by a user during operation, when theuser applies the force to the pivot arm 7008 to adjust the bone punchtool 7000 from the retracted position to the punch position. In at leastone example, the bone punch tool 7000 can include more than one lockingmember 7042, any number of which may be of different types.

The bone punch tool 7000 can comprise any of a variety of materialssufficient to withstand the forces of use. In some examples, one or moreelements of the bone punch tool 7000 comprises surgical material, forexample, metal. In at least one example, one or more elements of thebone punch tool 7000 can comprise heat-treated stainless steel. In someexamples, one or more elements of the bone punch tool 7000 can comprisecobalt, Nitinol, ceramic, or the like.

FIG. 181 is a perspective view of the bone punch tool 7000 of FIG. 180in a punch position, after the pivot arm proximal portion 7012 has movedin the punch direction 7020. The pivot arm distal portion 7010 haspivoted about the pivot point 7014, and the arcuate punch 7016 hasextended into the recess 7024 of the protrusion 7022. In the illustratedexample, the lip 7030 of the pivot arm distal portion 7010 is fullyseated in the shoulder 7028 of the housing 7026, such that the pivot arm7008 and the arcuate punch 7016 are prevented from further movement inthe punch direction 7020. In the punch position, the pivot arm proximalportion 7012 is separated from the support arm proximal portion 7006 bya second distance 7060 that is greater than the first distance 7050.

In order to retract the arcuate punch 7016 to return the bone punch tool7000 back to the retracted position, the pivot arm proximal portion 7012can be moved toward the support arm proximal portion 7006 in aretraction direction 7054. As the pivot arm 7008 moves in the retractiondirection 7054, the pivot arm distal portion 7010 pivots about the pivotpoint 7014 to retract the arcuate punch 7016. In at least one example,the locking member 7042 can include a biasing element that returns thebone punch tool 7000 from the punch position to the retracted positionwhen a force in the punch direction 7020 is reduced.

FIGS. 182A and 182B are a perspective view and a top view, respectively,of the bone punch tool 7000 of FIGS. 180 and 181 engaging a firstmanubrium portion 7070 in a retracted position, in accordance with atleast one example of the present disclosure. In the illustrated example,the u-shaped receptacle 7032 has received the first manubrium portion7070, such that the wall 7036 of the housing 7026 is in contact with acut surface 7072 of the first manubrium portion 7070 to align the bonepunch tool 7000 relative to the cut surface 7072 of the manubriumportion 7070. A completed punch hole 7074 has been formed in a secondmanubrium portion 7076. In the illustrated example, alignment guides7038, 7040, in the form of windows formed in the support arm 7002 andthe pivot arm 7008, respectively, can allow a user to align the bonepunch tool 7000 relative to the completed punch hole 7074 in the secondmanubrium portion 7076. For example, the user can place the windowdirectly over the completed punch hole 7074 to align the bone punch tool7000 to form a second punch hole substantially parallel to the completedpunch hole 7074. In the illustrated example, the bone punch tool 7000 isaligned with both the cut surface 7072 of the first manubrium portion7070 and the completed punch hole 7074 of the second manubrium portion7076.

FIGS. 183A and 183B are a perspective view and a top view, respectively,of the bone punch tool 7000 of FIGS. 180-182B engaging the firstmanubrium portion 7070 in a punch position, in accordance with at leastone example of the present disclosure. In the illustrated example, auser has applied a force to the pivot arm proximal portion 7012 in thepunch direction 7020 to separate the pivot arm proximal portion 7012from the support arm proximal portion 7006. The bone punch tool 7000remains aligned with the cut surface 7072 of the first manubrium portion7070 and the completed punch hole 7074 of the second manubrium portion7076, such that an arcuate punch hole 7078 formed in the first manubriumportion 7070 is aligned with the completed punch hole 7074 formed in thesecond manubrium portion 7076. The bone piercing tip 7018 of the arcuatepunch 7016 is driven through the first manubrium portion 7070 by theforce applied to the pivot arm 7008.

In at least one example, the protrusion 7022 can be configured to shieldother parts of a patient's anatomy from the bone piercing tip 7018. Inat least one example, the protrusion 7022 receives the bone piercing tip7018 and prevents further motion of the arcuate punch 7016 in the punchdirection 7020. In some examples, the protrusion 7022 is dimensionedsuch that the piercing tip 7018 cannot penetrate the protrusion 7022. Insome examples, the protrusion 7022 has a thickness of at leastapproximately 3 millimeters (0.118 inches). In at least one example, theprotrusion 7022 has a thickness of at least approximately 3.81millimeters (0.150 inches). In at least one example, the recess 7024extends through most of the thickness of the protrusion 7022, but doesnot extend completely through the protrusion 7022.

The arcuate punch hole 7078 formed by the arcuate punch 7016 can allow acurved needle, a band, or both, to pass through bone. In some practices,a curved needle is attached to a band implant to help guide the bandaround the intercostal tissue of the sternum for a closing procedure,however it can be preferable to thread the band through the sternumitself. Further, it can be preferable to thread the band through themanubrium due to the significant width of the bone in that region of thesternum. These curved needles can be blunt to reduce the risk ofinjuring the patient during use and could not easily be threaded throughbone on their own. The bone punch tool 7000 provides sufficient leveragefor a user (e.g., a surgeon) to easily puncture through bone to create apunch hole configured to receive the curved needle, a band, or both.

The arcuate punch 7016 can have an arcuate geometry similar to thearcuate geometry of the curved needle. In some example, the radius ofcurvature varies throughout the length of the arcuate punch 7016. In atleast one example, the arcuate punch 7016 has a radius of curvature ofabout 17.98-18.67 millimeters (0.708-0.735 inches). In at least oneexample, the arcuate punch 7016 has a radius of curvature of about18.29-20.12 millimeters (0.720-0.729 inches). In some examples thearcuate punch 7016 can be wider and thicker than the maximum width andthickness of the curved needle, the band, or both, so as to provide anarcuate punch hole 7078 with a clearance fit. In at least one example,the arcuate punch 7016 can have the same width and thickness as themaximum width and thickness of the curved needle, the band, or both, soas to provide an arcuate punch hole 7078 with a transition fit. In atleast one example, the arcuate punch 7016 can be narrower and thinnerthan the maximum width and thickness of the curved needle, the band, orboth, so as to provide an arcuate punch hole 7078 with an interferencefit. Further, in some examples, the width of the arcuate punch 7016 cancorrespond differently to the maximum width of the curved needle thanthe thickness of the arcuate punch 7016 corresponds to the maximumthickness.

FIG. 184 is a perspective view of a needle guide 8000, in accordancewith at least one example of the present disclosure. The needle guide8000 can include a handle 8002 at a proximal end 8004 and an arcuateportion 8006 at a distal end 8008. In some examples, the arcuategeometry of the arcuate portion 8006 of the needle guide 8000corresponds to the arcuate geometry of the arcuate punch 7016 (describedwith reference to FIGS. 180-183B), a curved needle, or both. In someexamples, the arcuate portion 8006 has a varying radius along itslength. In at least one example, the arcuate portion 8006 has a radiusof curvature of about 17.98-18.67 millimeters (0.708-0.735 inches). Inat least one example, the arcuate portion 8006 has a radius of curvatureof about 18.29-20.12 millimeters (0.720-0.729 inches). In at least oneexample, the arcuate portion 8006 can include a concave radius ofcurvature of about 18.6 millimeters (0.73 inches) and a convex radius ofcurvature of about 31.8 millimeters (1.25 inches) In some examples, thearcuate portion 8006 can be dimensioned so as to provide a clearance fitin an arcuate punch hole.

In some examples, the arcuate portion 8006 can include a graspingportion 8010 configured to grasp a tip of a curved needle. In at leastone example, the grasping portion 8010 can include at least one slot8012. In the illustrated example, the grasping portion 8010 includes anaperture 8014 and at least one slot 8012, such that the end of thearcuate portion 8006 is configured to expand with receipt of the needlewithin the aperture 8014, so as to grasp the needle with the graspingportion 8010. While the illustrated example depicts the grasping portion8010 as having an aperture 8014 with two intersecting slots 8012, otherexamples may have different arrangements of apertures or slots thatallow the grasping portion 8010 to grasp the tip of the curved needle.

In some examples, the handle 8002 of the needle guide 8000 can be curvedor bent. In at least one example, the handle 8002 can be shaped anddimensioned to provide ease of use while inserting and removing theneedle guide 8000 into an arcuate punch hole. Each of the handle 8002and the arcuate portion 8010 can comprise any of a variety of materials,for example, plastic, metal, composite material, a combination of theseor the like.

FIGS. 185A and 185B are perspective views of the needle guide 8000 ofFIG. 184 inserted through an arcuate hole 7074 in a manubrium portion7076, in accordance with at least one example of the present disclosure.In the illustrated example, arcuate hole punches 7074, 7078 have beenformed in the manubrium portions 7070, 7076 (for example, using the bonepunch tool 7000 and methods described above with reference to FIGS.180-183B), and a band 8020 has been threaded through one of the arcuateholes 7078, the band being attached to a curved needle 8022 having a tip8024. In order to facilitate threading the curved needle 8004 throughthe arcuate hole 7074 for the sternum closing procedure, in someexamples, the arcuate portion 8006 of the needle guide 8000 can beinserted into the arcuate hole 7074. In at least one example, thegrasping portion 8010 of the needle guide 8000 can pass entirely throughthe arcuate hole 7074.

FIGS. 186A and 186B are perspective views of the needle guide 8000 ofFIGS. 184-185B engaging the curved needle 8022, in accordance with atleast one example of the present disclosure. In the illustrated example,the curved needle 8022 has been inserted within the grasping portion8010 of the needle guide 8000, such that the grasping portion 8010grasps retains the tip 8024 of the curved needle 8022. In at least oneexample, the tip 8024 of the curved needle 8022 can be inserted into anaperture 8014 of the grasping portion 8010, and one or more slots 8012intersecting the aperture 8014 allow the grasping portion 8010 to expandwhile maintaining an interference fit. In at least one example, each ofthe aperture 8014 and the one or more slots 8012 have a length parallelto a length of the arcuate portion 8006.

FIGS. 187A and 187B are perspective views of the needle guide 8000 ofFIGS. 184-186B guiding the curved needle 8022 through the arcuate hole7074, in accordance with at least one example of the present disclosure.While the grasping portion 8010 of the needle guide 8000 continues tograsp the tip 8024 of the curved needle 8022, the handle 8002 of theneedle guide 8000 can be rotated, so as to remove the arcuate portion8006 from the arcuate hole 7074, and guide the arcuate needle 8022through the arcuate hole 7074. In at least one example, once the tip8024 (or a greater portion) of the curved needle 8022 emerges from thearcuate hole 7074, the needle guide 8000 can be removed from the tip8024 of the curved needle 8022, and the sternum closing procedure canproceed with the threaded arcuate holes 7074, 7078.

The bone punch tool 7000 and the needle guide 8000 described withreference to FIGS. 180-187B can allow for formation of an arcuate punchhole through a manubrium or other bone portion and efficient threadingof the arcuate punch hole using a curved needle. Some other bone punchescannot accommodate a curved needle. Some other bone punches cannot forman arcuate punch hole. Some other bone punches require squeezing handlestogether to transition to a punched position. Some other bone punches donot provide sufficient leverage to punch through bone easily. Some otherbone punches are inefficient or cumbersome.

The foregoing description of the embodiments has been provided forpurposes of illustration and description. It is not intended to beexhaustive or to limit the disclosure. Individual elements or featuresof a particular embodiment are generally not limited to that particularembodiment, but, where applicable, are interchangeable and can be usedin a selected embodiment, even if not specifically shown or described.The same may also be varied in many ways. Such variations are not to beregarded as a departure from the disclosure, and all such modificationsare intended to be included within the scope of the disclosure.

1. A bone punch apparatus comprising: a support arm having a support armproximal portion and a support arm distal portion; a pivot arm having apivot arm proximal portion and a pivot arm distal portion, the pivot armdistal portion pivotably coupled to the support arm distal portion; andan arcuate punch configured to punch through bone, the arcuate punchcoupled to the pivot arm distal portion; wherein the pivot arm proximalportion is configured to be moved away from the support arm proximalportion to cause the arcuate punch to extend into a punch position. 2.The bone punch apparatus of claim 1, wherein the pivot arm proximalportion is configured to be moved toward the support arm proximalportion to cause the arcuate punch to retract into a retracted position.3. The bone punch apparatus of claim 1, wherein the pivot arm pivotsabout a pivot point positioned at the support arm distal portion at acenter of curvature of the arcuate punch.
 4. The bone punch apparatus ofclaim 1, further comprising: a protrusion extending from the support armdistal portion and configured to receive a bone piercing tip of thearcuate punch when in the punch position.
 5. The bone punch apparatus ofclaim 4, further comprising: a housing coupled to the support arm distalportion, the housing and the protrusion together defining a receptacleconfigured to receive a bone portion.
 6. The bone punch apparatus ofclaim 5, wherein the receptacle is a u-shaped receptacle configured toreceive a portion of a sternum.
 7. The bone punch apparatus of claim 1,wherein the arcuate punch is configured to form an arcuate hole througha bone portion.
 8. The bone punch apparatus of claim 1, furthercomprising: a locking member configured to urge the pivot arm proximalportion toward the support arm proximal portion.
 9. A bone punchapparatus comprising: a support arm having a support arm proximalportion, a support arm distal portion, and a support arm alignmentguide; a pivot arm having a pivot arm proximal portion and a pivot armdistal portion, the pivot arm distal portion pivotably coupled to thesupport arm distal portion; and an arcuate punch configured to punchthrough bone, the arcuate punch coupled to the pivot arm distal portion;wherein the support arm alignment guide is configured to indicate anorientation of the arcuate punch.
 10. The bone punch apparatus of claim9, wherein: the pivot arm proximal portion is configured to be movedaway from the support arm proximal portion to cause the arcuate punch toextend into a punch position; and the pivot arm proximal portion isconfigured to be moved toward the support arm proximal portion to causethe arcuate punch to retract into a retracted position.
 11. The bonepunch apparatus of claim 9, wherein the support arm alignment guidecomprises a window.
 12. The bone punch apparatus of claim 11, wherein awidth of the window corresponds to a width of the arcuate punch.
 13. Thebone punch apparatus of claim 9, wherein the support arm alignment guideis configured to align with a completed punch hole.
 14. The bone punchapparatus of claim 9, wherein the pivot arm comprises a pivot armalignment guide configured to indicate an orientation of the arcuatepunch.
 15. A system comprising: a bone punch tool configured to form anarcuate hole through a bone, the bone punch tool comprising: a supportarm having a support arm proximal portion and a support arm distalportion; a pivot arm having a pivot arm proximal portion and a pivot armdistal portion, the pivot arm distal portion pivotably coupled to thesupport arm distal portion; and an arcuate punch configured to punchthrough the bone, the arcuate punch coupled to the pivot arm distalportion; wherein the pivot arm proximal portion is configured to bemoved away from the support arm proximal portion to cause the arcuatepunch to extend into a punch position; and a needle guide configured toguide a needle through the arcuate hole.
 16. The system of claim 15,wherein the arcuate punch is dimensioned to form the arcuate hole withgeometry corresponding to an arcuate geometry of the needle.
 17. Thesystem of claim 16, wherein the needle guide comprises: a handle; anarcuate portion coupled to the handle, the arcuate portion configured tobe inserted into the arcuate hole; and a grasping portion at an end ofthe arcuate portion, the grasping portion configured to grasp a tip ofthe needle.
 18. The system of claim 17, wherein the grasping portioncomprises a slot formed in the arcuate portion.
 19. The system of claim17, wherein the grasping portion comprises an aperture and at least oneslot intersecting the aperture, such that the end of the arcuate portionis configured to expand with receipt of the needle within the aperture.20. The system of claim 17, wherein the arcuate portion is configured tobe removed from the arcuate hole while grasping the needle, such thatthe needle guide is configured to guide the needle through the arcuatehole.